LetsGetChecked is a global healthcare solutions company that provides the tools to manage health from home through health testing, virtual care, genetic sequencing, and medication delivery for a wide range of health and wellness conditions. LetsGetChecked's end-to-end model includes manufacturing, logistics, lab analysis, physician support, and prescription fulfillment. Founded in 2015 and co-headquartered in Dublin and Atlanta, LetsGetChecked empowers people to take control of their health and live longer, happier lives. Quality Assurance associate We are seeking a seeking a Quality Assurance Associate to join our dynamic team at our Manufacturing Facility located in Dublin, where we manufacture sample collection kits. In this role, you'll be at the forefront of ensuring product integrity through conducting thorough quality inspection activities, including visual inspections, dimensional measurements, and material testing. Responsibilities include, but are not limited to, the following: Ensuring the quality of sample collection kits by following relevant procedures, conducting incoming inspections of raw materials to confirm they meet specifications and acceptance criteria. Prior to product release, reviewing batch paperwork and maintaining compliant documentation and records according to site procedures for record control. Promptly notifying management of any product quality issues, documenting on-hold notices and quality alerts efficiently, and participating in continuous improvement projects and initiatives at the site. Supporting applicable processes within the Quality Management System (such as Change Controls, Documentation Management, CAPAs/NCRs, Audit Readiness, and Supplier Quality Management). Assisting management in compiling and presenting daily and weekly Quality metrics. What are we looking for? A Bachelor's degree, preferably in Science, Quality, Engineering, or a related field, with 1-2 years of experience in the quality assurance department of the medical device or pharmaceutical industry. Demonstrates keen attention to detail and capable of managing multiple conflicting priorities with minimal supervision and timely escalation of identified issues to management. Strong communication skills, both written and verbal, along with exceptional organizational abilities. Proficient technical comprehension, capable of understanding and executing steps outlined in relevant procedures. Exceptional troubleshooting, analytical, problem-solving, and root-cause analysis skills. Ability to emphasize the importance of ensuring product quality and compliance with regulations. Possesses a basic understanding of ISO 13485:2016, FDA 21 CFR Part 820, and other applicable regulations. Alongside base salary of €31,000 - €33,000 , we offer a range of benefits including: Health insurance and an Employee Assistance Programme Annual Compensation Reviews After 90 days you will be eligible to avail of Flexible Annual Leavewhere you are not restricted to a specific number of holiday days/annual leave Free monthly LetsGetChecked tests as we are not only focused on the well being of our patients but also the well being of our teams A referral bonus programme to reward you for helping us hire the best talent Internal Opportunities and Careers Clinics to help you progress your career within the company. Bike to work scheme - and secure bike storage onsite. Maternity, Paternity, Parental and Wedding leave. Why LetsGetChecked At LetsGetChecked, we are revolutionizing healthcare by making it more accessible, convenient, and personalized. Our mission is to empower individuals with the knowledge and tools they need to manage their health proactively, so they can live longer, happier lives. By joining our team, you will be part of a dynamic and innovative company that is dedicated to improving lives through cutting-edge technology and compassionate care. We value our employees and invest in their growth, offering opportunities for professional development and career advancement. Together, we can make a meaningful impact on the future of healthcare and help people take control of their health journey. Join us in our commitment to transforming healthcare for the better. Our Commitment to Diversity, Equity, and Inclusion At LetsGetChecked, we are committed to fostering an inclusive environment that celebrates diversity in all its forms. We believe that the diversity of thought, background, and experience strengthens our teams and drives innovation. We are an equal-opportunity employer and do not discriminate on the basis of race, ethnicity, religion, color, place of birth, sex, gender identity or expression, sexual orientation, age, marital status, military service status, or disability status. Our goal is to ensure that everyone feels valued and empowered to thrive. Interested in building your career at LetsGetChecked? Get future opportunities sent straight to your email. Accepted file types: pdf, doc, docx, txt, rtf Enter manually Accepted file types: pdf, doc, docx, txt, rtf LinkedIn Profile Website Are you currently based in the Republic of Ireland with full working rights? * Select... Please acknowledge the following Recruitment Privacy Policy. * Select... By submitting your application, you agree that LetsGetChecked may collect your personal data for recruiting, and related purposes. LetsGetChecked's Privacy Notice explains what personal information we may process, where we may process your personal information, our purposes for processing your personal information, and the rights you can exercise over LetsGetChecked's use of your personal information. You can view the appropriate privacy policy below: Do you hold a bachelor's degree, preferably in Science, Quality, Engineering, or a related field, with 1-2 years of experience in the quality assurance department of the medical device or pharmaceutical industry? * Select... Voluntary Self-Identification For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file. As set forth in LetsGetChecked’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law. If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Select... Voluntary Self-Identification of Disability Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 04/30/2026 Voluntary Self-Identification of Disability Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 04/30/2026 Why are you being asked to complete this form? We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years. Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp . How do you know if you have a disability? A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to: Alcohol or other substance use disorder (not currently using drugs illegally) Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS Blind or low vision Cancer (past or present) Cardiovascular or heart disease Celiac disease Cerebral palsy Deaf or serious difficulty hearing Diabetes Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders Epilepsy or other seizure disorder Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome Intellectual or developmental disability Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD Missing limbs or partially missing limbs Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS) Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities Partial or complete paralysis (any cause) Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema Short stature (dwarfism) Traumatic brain injury Disability Status Select... PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete. #J-18808-Ljbffr
LetsGetChecked is a global healthcare solutions company that provides the tools to manage health from home through health testing, virtual care, genetic sequencing, and medication delivery for a wide range of health and wellness conditions. LetsGetChecked's end-to-end model includes manufacturing, logistics, lab analysis, physician support, and prescription fulfillment. Founded in 2015 and co-headquartered in Dublin and Atlanta, LetsGetChecked empowers people to take control of their health and live longer, happier lives. Senior Quality Engineer We are seeking a detail-oriented Senior Quality Engineer to join our dynamic team at our Manufacturing Facility in Dublin, to ensure our products and processes comply with relevant regulations and standards, including ISO 13485, 21 CFR Part 820, MDR 2017/745, IVDR 2017/746, and ISO 14971. This role involves reviewing and approving change controls, validating manufacturing equipment and processes, participating in audits, leading risk management activities, and providing mentorship to the Quality team. Responsibilities include, but are not limited to, the following: Evaluate current products and processes to ensure compliance with applicable regulations and standards. Review and approve change controls, guiding the team through the change process to maintain compliance. Review and approve validation deliverables for manufacturing equipment and processes and identify effective process controls. Participate in internal and external audits, taking on various roles within the audit team and leading audit preparation, resolution of audit findings by liaising with process owners and managers. Lead risk management activities, maintain risk management documentation and assess risk mitigation techniques, identify potential failure modes, defect frequency, severity, risk, process controls, etc. Collaborate with cross-functional teams to implement changes and automated production systems for efficient quality issue resolution. Provide mentorship to Quality team personnel on meeting daily work priorities and team goals with direction from management and technical guidance in identifying and resolving quality issues using six sigma, lean, and related tools/techniques. Responsible for analyzing and summarizing potential issues by assessing impact on customer safety and product quality and to make decisions related to the disposition of non-conforming product. Contribute towards investigation of CAPAs and non-conformances and review applicable records and documentation for completion at critical phases. Stay updated on regulatory changes and industry best practices, integrating quality into all aspects of work, and offering problem-solving recommendations to the operations and engineering teams. What we are looking for… Minimum 5 years of relevant experience in an engineering or quality role, or an advanced degree preferably in Quality, Biomedical Engineering with a minimum 3 years of experience in a quality department. Good working knowledge of ISO 13485, 21 CFR Part 820, MDR 2017/745, IVDR 2017/746, ISO 14971. Proficient in using SAP S/4 HANA, particularly the Quality Management (QM) module. Experience with internal and external audits, and a professional certification in Quality Auditing (i.e. Certified Lead Auditor or Internal Auditor) is required. Experience in reviewing technical documentation, assessing impact of proposed changes on the QMS by working constructively with stakeholders across all business areas of the organization. Experience with new product introduction (Class II medical devices, Class A IVDs) and have significant expertise in validation engineering, risk analysis and documenting risk management reports. Knowledge of root cause analysis, continuous improvement activities and execution and verification of effectiveness techniques. Hands-on using Statistics, Lean and Six Sigma methodologies is required, Minitab experience is an advantage. Ability to work independently in a fast-paced medical device manufacturing environment, and able to multitask and prioritize tasks to meet high expectations and tight deadlines. Project and people management skills are needed, along with the ability to mentor the team and foster a positive work environment. Excellent analytical, troubleshooting, process improvement, critical thinking, and decision-making skills. Strong technical writing and exceptional verbal communication skills. Alongside a base salary of €50,000 - €55,000 we offer a range of benefits including: Health insurance and an Employee Assistance Programme. Annual Compensation Reviews. After 90 days you will be eligible to avail of Flexible Annual Leave where you are not restricted to a specific number of holiday days / annual leave. Free monthly LetsGetChecked tests as we are not only focused on the well being of our patients but also the well being of our teams. A referral bonus programme to reward you for helping us hire the best talent. Internal Opportunities and Careers Clinics to help you progress your career within the company. Bike to work scheme - and secure bike storage onsite. Maternity, Paternity, Parental and Wedding leave. Why LetsGetChecked At LetsGetChecked, we are revolutionizing healthcare by making it more accessible, convenient, and personalized. Our mission is to empower individuals with the knowledge and tools they need to manage their health proactively, so they can live longer, happier lives. By joining our team, you will be part of a dynamic and innovative company that is dedicated to improving lives through cutting-edge technology and compassionate care. We value our employees and invest in their growth, offering opportunities for professional development and career advancement. Together, we can make a meaningful impact on the future of healthcare and help people take control of their health journey. Join us in our commitment to transforming healthcare for the better. Our Commitment to Diversity, Equity, and Inclusion At LetsGetChecked, we are committed to fostering an inclusive environment that celebrates diversity in all its forms. We believe that the diversity of thought, background, and experience strengthens our teams and drives innovation. We are an equal-opportunity employer and do not discriminate on the basis of race, ethnicity, religion, color, place of birth, sex, gender identity or expression, sexual orientation, age, marital status, military service status, or disability status. Our goal is to ensure that everyone feels valued and empowered to thrive. #J-18808-Ljbffr
LetsGetChecked is a global healthcare solutions company that provides the tools to manage health from home through health testing, virtual care, genetic sequencing, and medication delivery for a wide range of health and wellness conditions. LetsGetChecked's end-to-end model includes manufacturing, logistics, lab analysis, physician support, and prescription fulfillment. Founded in 2015 and co-headquartered in Dublin and Atlanta, LetsGetChecked empowers people to take control of their health and live longer, happier lives. Manufacturing Quality Coordinator The Manufacturing Quality Coordinator will be responsible for ensuring that our manufacturing processes, products and systems are in compliance with our requirements. The Manufacturing Quality Coordinator will identify and manage investigations of non-conforming events and complaints. Responsibilities: Act as the Manufacturing Lead in regards to process monitoring and key quality control points ensuring negative trends are addressed. Ensure that all products manufactured meet the specifications, performance & quality criteria of end users, customers, regulatory authorities and the company. Process Audits of the manufacturing lines to ensure the product being manufactured and our equipment and processes comply with all requirements. Owner of Non-conformances, investigations, change controls, CAPA’s. Owner of Process related SOPs GDP documentation. Maintain and produce technical documents in accordance with Quality systems. Represent Manufacturing at appropriate meetings, projects. Identify and suggest improvements to current equipment, processes, and procedures to streamline the manufacturing activities while ensuring high standards of quality. Be an active lead on Continuous Improvement Projects by delivering on actions committed to, critiquing current methods, and suggesting alternatives/improvements. Working as an individual contributor and in a team. What we are looking for… 3 years’ experience in a Regulated industry environment Quality compliance background – GDP GMP GXP Familiarity with FDA, HPRA, NSAI, ISO 13485 and medical standards is required. Proficient in Microsoft Office, Google Sheets data analysis, including the use of formulas, charts and pivot tables. Excellent attention to detail, thorough in approach, checks work systematically to ensure it is sufficiently detailed and reliable. Adaptable, demonstrates a willingness to take the initiative with problems and opportunities. Strong communication & influencing skills and ability to effectively manage a simultaneous range of diverse activities. A Bachelor's Degree in Manufacturing Engineering, Quality Engineering, Life Sciences or related field. SAP experience would be an advantage Green Belt in Lean Six Sigma would be a distinct advantage. Benefits: Alongside a base salary of €40,000 - €45,000 we offer a range of benefits including: Health insurance and an Employee Assistance Programme Pension matching contribution Annual Compensation Reviews LetsGetChecked has a Flexible Annual Leave Policy Free monthly LetsGetChecked tests as we are not only focused on the well being of our patients but also the well being of our teams A referral bonus programme to reward you for helping us hire the best talent Internal Opportunities and Careers Clinics to help you progress your career within the company. Bike to work scheme - and secure bike storage onsite. Maternity, Paternity, Parental and Wedding leave. Why LetsGetChecked At LetsGetChecked, we are revolutionizing healthcare by making it more accessible, convenient, and personalized. Our mission is to empower individuals with the knowledge and tools they need to manage their health proactively, so they can live longer, happier lives. By joining our team, you will be part of a dynamic and innovative company that is dedicated to improving lives through cutting-edge technology and compassionate care. We value our employees and invest in their growth, offering opportunities for professional development and career advancement. Together, we can make a meaningful impact on the future of healthcare and help people take control of their health journey. Join us in our commitment to transforming healthcare for the better. Our Commitment to Diversity, Equity, and Inclusion At LetsGetChecked, we are committed to fostering an inclusive environment that celebrates diversity in all its forms. We believe that the diversity of thought, background, and experience strengthens our teams and drives innovation. We are an equal-opportunity employer and do not discriminate on the basis of race, ethnicity, religion, color, place of birth, sex, gender identity or expression, sexual orientation, age, marital status, military service status, or disability status. Our goal is to ensure that everyone feels valued and empowered to thrive. #J-18808-Ljbffr
LetsGetChecked is a global healthcare solutions company that provides the tools to manage health from home through health testing, virtual care, genetic sequencing, and medication delivery for a wide range of health and wellness conditions. LetsGetChecked's end-to-end model includes manufacturing, logistics, lab analysis, physician support, and prescription fulfillment. Founded in 2015 and co-headquartered in Dublin and Atlanta, LetsGetChecked empowers people to take control of their health and live longer, happier lives. The Regulatory Affairs Specialist’s role involves working cross-functionally with clinical, quality, and engineering teams during the design process, test development, jurisdiction expansion, and product lifecycle. This includes a range of activities related to marketing authorization, submissions, vigilance, adverse event reporting, and clinical evaluation within the In-Vitro Diagnostics/Medical Device environment. The primary function of this role is to support the management and maintenance of Regulatory Affairs requirements in the global jurisdictions in which LetsGetChecked operates, ensuring smooth and efficient processes. The Quality and Compliance team based in Dublin is responsible for global regulation, managing pre- and post-market regulation for various product classifications across Europe, the USA, and Canada. Responsibilities and Duties Act as a contributing Regulatory Team member for assigned regulatory projects. Creation and review of SOPs, change control forms, CAPA/NCR process. Support role to Quality team. Support role in both Internal and External Audits, particularly ISO 13485:2016. Work as part of a multi-functional team by providing regulatory input to new product development, including artwork approvals, label claims, IFUs, and associated supporting documentation. Reviewing product claims in social media and other marketing material. Contribute to ensuring regulatory requirements are met in a planned and timely manner to avoid delays in approvals. Support the development and implementation of the Regulatory Strategy. Stay updated on US, EU, and other global regulatory guidelines. Build and maintain strong relationships with Regulatory Authorities, Consultants, and internal departments. Support the preparation of regulatory documents to EU competent authorities and the US FDA including device listings, establishment registrations, adverse event reporting, and substantial changes. Assist in the maintenance and compilation of EU IVDR and MDR technical files for in vitro diagnostic sample collection kits (IVD Class A) and Class IIa medical devices. Participate in Continuous Improvement Initiatives to enhance department functions. Actively participate and employ effective communication practices with internal customers (Supply Chain, Quality, Legal, Clinical, Customer Care). Review of Product complaints and liaise with the complaints team on open complaints. Assist in complaint investigation as necessary. Support role in validation activities. Prepare status reports and metrics for assigned projects. Perform assigned work according to current good regulatory practice and in compliance with current legislation and regulatory guidelines at all times. Any other duties as assigned by your Manager. What are we looking for? Life sciences degree (BSc or equivalent). 1-3 years of regulatory experience in the medical device or IVD industry. Experience assisting with the maintenance of EU technical files. Hardworking, self-motivated, and with attention to detail. Working knowledge of the USA and EU regulatory requirements and procedures. Familiarity with MS Office, or equivalent. Excellent written and oral communication skills, attention to detail, and the ability to handle multiple projects. Preparation of relevant technical, safety, and performance technical documents to support submissions, in collaboration with Technical/Clinical/Labelling experts. Understanding of Regulatory strategy and determination of documentation requirements, timelines, budgets and filing options. Compliance with SOPs, Change controls and regulatory best practices. Alongside a base salary of €45,000 - €50,000 we offer a range of benefits including: Health insurance and an Employee Assistance Programme. Annual Compensation Reviews. LetsGetChecked has a flexible Annual Leave policy. Free monthly LetsGetChecked tests as we are not only focused on the well being of our patients but also the well being of our teams. A referral bonus programme to reward you for helping us hire the best talent. Internal Opportunities and Careers Clinics to help you progress your career within the company. Bike to work scheme - and secure bike storage onsite. Maternity, Paternity, Parental and Wedding leave. Why LetsGetChecked At LetsGetChecked, we are revolutionizing healthcare by making it more accessible, convenient, and personalized. Our mission is to empower individuals with the knowledge and tools they need to manage their health proactively, so they can live longer, happier lives. By joining our team, you will be part of a dynamic and innovative company that is dedicated to improving lives through cutting-edge technology and compassionate care. We value our employees and invest in their growth, offering opportunities for professional development and career advancement. Together, we can make a meaningful impact on the future of healthcare and help people take control of their health journey. Join us in our commitment to transforming healthcare for the better. Our Commitment to Diversity, Equity, and Inclusion At LetsGetChecked, we are committed to fostering an inclusive environment that celebrates diversity in all its forms. We believe that the diversity of thought, background, and experience strengthens our teams and drives innovation. We are an equal-opportunity employer and do not discriminate on the basis of race, ethnicity, religion, color, place of birth, sex, gender identity or expression, sexual orientation, age, marital status, military service status, or disability status. Our goal is to ensure that everyone feels valued and empowered to thrive. #J-18808-Ljbffr
LetsGetChecked is a global healthcare solutions company that provides the tools to manage health from home through health testing, virtual care, genetic sequencing, and medication delivery for a wide range of health and wellness conditions. LetsGetChecked's end-to-end model includes manufacturing, logistics, lab analysis, physician support, and prescription fulfillment. Founded in 2015 and co-headquartered in Dublin and Atlanta, LetsGetChecked empowers people to take control of their health and live longer, happier lives. The People Operations Manager, reporting to the VP, People Operations (EU), will oversee the planning, management, development, and coordination of LetsGetChecked’s HR policies, procedures, and legal/compliance activities while providing strategic HR support to the Technology department, aligning HR initiatives with business objectives and fostering a positive and productive work environment. Duties/Responsibilities: HR Operations: Partner with the Technology Department to manage daily HR functions that support the employee life cycle and improve employee engagement and company culture by identifying areas of improvement in HR policies, processes, and procedures. Strategic HR Planning: Work with the Technology department management team and HR leadership to understand the organisation's goals and strategy. Then, develop and champion HR strategies that support the company's short-term and long-term business goals. Employee Relations: Provide guidance and answer questions related to HR policies and procedures for employees and managers. Act as a mediator and advisor to ensure that company policies and procedures are applied fairly and consistently when resolving employee relations issues. Serve as the main point of contact for employees and managers. HR Compliance: Stay updated on relevant legislation and implement necessary changes. Maintain and review company policies and practices to ensure compliance with current local employment laws, regulations and recommended best practices. Stay informed of relevant legislative changes and implement necessary updates to ensure ongoing compliance. Policy Development: Collaborate with HR leadership to create, update and communicate HR policies and procedures. HR Metrics and Reporting: Analyze HR data and track metrics to identify insights and provide recommendations for ongoing improvements. Employee Feedback: Assess employee satisfaction and pinpoint areas for improvement through employee communication. Payroll Support: Collaborate with our internal payroll team and external partners to address payroll inquiries. Complete other tasks as assigned by the VP, People Operations (EU) or Leadership. Requirements: 3+ years of proven work experience as an HRBP or HR Manager preferably within the Technology sector, with in-depth knowledge of HR best practices, employment laws, processes and procedures and regulations, preferably in a high-growth technology or healthcare company. Experience partnering with geographically dispersed teams; exposure to Portugal, Ireland and US-based employee groups beneficial. Ability to effectively communicate and collaborate with various stakeholders to understand business needs utilizing strong business acumen to provide HR solutions. Demonstrated success in developing and implementing HR strategies that support organisational goals. Exceptional interpersonal skills with the ability to influence and collaborate effectively. Alongside a base salary of €55,000-€60,000 we offer a range of benefits including: Health insurance and an Employee Assistance Programme Annual Compensation Reviews LetsGetChecked has a Flexible Annual Leave Policy Free monthly LetsGetChecked tests A referral bonus programme to reward you for helping us hire the best talent Internal Opportunities and Careers Clinics to help you progress your career within the company. Bike to work scheme - and secure bike storage onsite. Maternity, Paternity, Parental and Wedding leave. Why LetsGetChecked At LetsGetChecked, we are revolutionizing healthcare by making it more accessible, convenient, and personalized. Our mission is to empower individuals with the knowledge and tools they need to manage their health proactively, so they can live longer, happier lives. By joining our team, you will be part of a dynamic and innovative company that is dedicated to improving lives through cutting-edge technology and compassionate care. We value our employees and invest in their growth, offering opportunities for professional development and career advancement. Together, we can make a meaningful impact on the future of healthcare and help people take control of their health journey. Join us in our commitment to transforming healthcare for the better. Our Commitment to Diversity, Equity, and Inclusion At LetsGetChecked, we are committed to fostering an inclusive environment that celebrates diversity in all its forms. We believe that the diversity of thought, background, and experience strengthens our teams and drives innovation. We are an equal-opportunity employer and do not discriminate on the basis of race, ethnicity, religion, color, place of birth, sex, gender identity or expression, sexual orientation, age, marital status, military service status, or disability status. Our goal is to ensure that everyone feels valued and empowered to thrive. #J-18808-Ljbffr
LetsGetChecked is a global healthcare solutions company that provides the tools to manage health from home through health testing, virtual care, genetic sequencing, and medication delivery for a wide range of health and wellness conditions. LetsGetChecked's end-to-end model includes manufacturing, logistics, lab analysis, physician support, and prescription fulfillment. Founded in 2015 and co-headquartered in Dublin and Atlanta, LetsGetChecked empowers people to take control of their health and live longer, happier lives. The Regulatory Affairs Specialist’s role involves working cross-functionally with clinical, quality, and engineering teams during the design process, test development, jurisdiction expansion, and product lifecycle. This includes a range of activities related to marketing authorization, submissions, vigilance, adverse event reporting, and clinical evaluation within the In-Vitro Diagnostics/Medical Device environment. The primary function of this role is to support the management and maintenance of Regulatory Affairs requirements in the global jurisdictions in which LetsGetChecked operates, ensuring smooth and efficient processes. The Quality and Compliance team based in Dublin is responsible for global regulation, managing pre- and post-market regulation for various product classifications across Europe, the USA, and Canada. Responsibilities and Duties Act as a contributing Regulatory Team member for assigned regulatory projects. Creation and review of SOPS, change control forms, CAPA/NCR process. Support role to Quality team. Support role in both Internal and External Audits, particularly ISO 13485:2016. Work as part of a multi-functional team by providing regulatory input to new product development, including artwork approvals, label claims, IFUs, and associated supporting documentation. Reviewing product claims in social media and other marketing material. Contribute to ensuring regulatory requirements are met in a planned and timely manner to avoid delays in approvals. Support the development and implementation of the Regulatory Strategy. Stay updated on US, EU, and other global regulatory guidelines. Build and maintain strong relationships with Regulatory Authorities, Consultants, and internal departments. Support the preparation of regulatory documents to EU competent authorities and the US FDA including device listings, establishment registrations, adverse event reporting, and substantial changes. Assist in the maintenance and compilation of EU IVDR and MDR technical files for in vitro diagnostic sample collection kits (IVD Class A) and Class IIa medical devices. Participate in Continuous Improvement Initiatives to enhance department functions. Actively participate and employ effective communication practices with internal customers (Supply Chain, Quality, Legal, Clinical, Customer Care). Review of Product complaints and liaise with the complaints team on open complaints. Assist in complaint investigation as necessary. Support role in validation activities. Prepare status reports and metrics for assigned projects. Perform assigned work according to current good regulatory practice and in compliance with current legislation and regulatory guidelines at all times. Any other duties as assigned by your Manager. What are we looking for? Life sciences degree (BSc or equivalent). 1-3 years of regulatory experience in the medical device or IVD industry. Experience assisting with the maintenance of EU technical files. Hardworking, self-motivated, and with attention to detail. Working knowledge of the USA and EU regulatory requirements and procedures. Familiarity with MS Office, or equivalent. Excellent written and oral communication skills, attention to detail, and the ability to handle multiple projects. Preparation of relevant technical, safety, and performance technical documents to support submissions, in collaboration with Technical/Clinical/Labelling experts. Understanding of Regulatory strategy and determination of documentation requirements, timelines, budgets and filing options. Compliance with SOPs, Change controls and regulatory best practices. Alongside a base salary of €45,000 - €50,000 we offer a range of benefits including: Health insurance and an Employee Assistance Programme. Annual Compensation Reviews. LetsGetChecked has a flexible Annual Leave policy. Free monthly LetsGetChecked tests as we are not only focused on the well being of our patients but also the well being of our teams. A referral bonus programme to reward you for helping us hire the best talent. Internal Opportunities and Careers Clinics to help you progress your career within the company. Bike to work scheme - and secure bike storage onsite. Maternity, Paternity, Parental and Wedding leave. Why LetsGetChecked At LetsGetChecked, we are revolutionizing healthcare by making it more accessible, convenient, and personalized. Our mission is to empower individuals with the knowledge and tools they need to manage their health proactively, so they can live longer, happier lives. By joining our team, you will be part of a dynamic and innovative company that is dedicated to improving lives through cutting-edge technology and compassionate care. We value our employees and invest in their growth, offering opportunities for professional development and career advancement. Together, we can make a meaningful impact on the future of healthcare and help people take control of their health journey. Join us in our commitment to transforming healthcare for the better. Our Commitment to Diversity, Equity, and Inclusion At LetsGetChecked, we are committed to fostering an inclusive environment that celebrates diversity in all its forms. We believe that the diversity of thought, background, and experience strengthens our teams and drives innovation. We are an equal-opportunity employer and do not discriminate on the basis of race, ethnicity, religion, color, place of birth, sex, gender identity or expression, sexual orientation, age, marital status, military service status, or disability status. Our goal is to ensure that everyone feels valued and empowered to thrive. #J-18808-Ljbffr
LetsGetChecked is a global healthcare solutions company that provides the tools to manage health from home through health testing, virtual care, genetic sequencing, and medication delivery for a wide range of health and wellness conditions. LetsGetChecked's end-to-end model includes manufacturing, logistics, lab analysis, physician support, and prescription fulfillment. Founded in 2015 and co-headquartered in Dublin and Atlanta, LetsGetChecked empowers people to take control of their health and live longer, happier lives. Junior Implementation Administrator The Junior Implementation Administrator will play a critical role in ensuring successful client implementations! This position supports the implementation team by building and maintaining the essential technical framework for client onboarding and campaign execution. Responsibilities include creating client templates, configuring results campaigns, managing client configurations, and updating documentation. Proficiency in mail merge, Google Sheets, Smartsheet, Salesforce, and Stripo is essential for success in this role. Responsibilities: Support the implementation team in all aspects of client onboarding, including building and maintaining technical infrastructure. Create and update client templates, incorporating client feedback and ensuring high levels of detail and accuracy. Configure and manage campaigns and configurations. Update and maintain documentation. Ensure quality assurance through testing of client templates, results campaigns, and client configurations. Develop proficiency in a variety of tools to include Google Sheets, Smartsheet, Salesforce, Braze, and Stripo. Assist with any and all other duties related to client onboarding as assigned. What we're looking for... Familiarity with some of the related tools (mail merge, Google Sheets, Smartsheet, Salesforce, Stripo) is a plus, but a willingness to learn is key! Strong organizational skills and the ability to manage multiple tasks. Excellent verbal and written communication skills. Ability to work independently and as part of a team. A positive attitude and a desire to learn and grow within the company. A detail-oriented approach and commitment to accuracy. Alongside base salary of €35,000 - €45,000 , we offer a range of benefits including: Health insurance and an Employee Assistance Programme. Annual Compensation Reviews. LetsGetChecked has a Flexible Annual Leave Policy. Free monthly LetsGetChecked tests as we are not only focused on the well-being of our patients but also the well-being of our teams. A referral bonus programme to reward you for helping us hire the best talent. Internal Opportunities and Careers Clinics to help you progress your career within the company. Bike to work scheme - and secure bike storage onsite. Maternity, Paternity, Parental, and Wedding leave. Why LetsGetChecked At LetsGetChecked, we are revolutionizing healthcare by making it more accessible, convenient, and personalized. Our mission is to empower individuals with the knowledge and tools they need to manage their health proactively, so they can live longer, happier lives. By joining our team, you will be part of a dynamic and innovative company that is dedicated to improving lives through cutting-edge technology and compassionate care. We value our employees and invest in their growth, offering opportunities for professional development and career advancement. Together, we can make a meaningful impact on the future of healthcare and help people take control of their health journey. Join us in our commitment to transforming healthcare for the better. Our Commitment to Diversity, Equity, and Inclusion At LetsGetChecked, we are committed to fostering an inclusive environment that celebrates diversity in all its forms. We believe that the diversity of thought, background, and experience strengthens our teams and drives innovation. We are an equal-opportunity employer and do not discriminate on the basis of race, ethnicity, religion, color, place of birth, sex, gender identity or expression, sexual orientation, age, marital status, military service status, or disability status. Our goal is to ensure that everyone feels valued and empowered to thrive. #J-18808-Ljbffr
LetsGetChecked is a global healthcare solutions company that provides the tools to manage health from home through health testing, virtual care, genetic sequencing, and medication delivery for a wide range of health and wellness conditions. LetsGetChecked's end-to-end model includes manufacturing, logistics, lab analysis, physician support, and prescription fulfillment. Founded in 2015 and co-headquartered in Dublin and Atlanta, LetsGetChecked empowers people to take control of their health and live longer, happier lives. Position Description: Research, develop and apply new innovative technologies to our healthcare products Be an advocate of state-of-the-art technology and engineering approaches Build new products and solutions that transform our industry Write clean, maintainable code using the best industry standards for mission-critical services Work with autonomy to find solutions to complex problems and be flexible and responsive to changing requirements and priorities Be a team member on a variety of projects including new product/component development, proofs of concept, and reengineering initiatives among others The ability for critical thinking outside your immediate sphere of responsibility Have experience with commercial products and environments (not just internally focused) Have a collaborative working style and contribute to the development of our technical communities across the company Requirements: BS or MS in Computer Science (or related technical discipline) or equivalent industry experience Up to 3+ years as a full-stack developer Experience in geo-distributed Cloud environments (preferably AWS) Experience writing and maintaining automated tests to ensure code quality An understanding of RESTful architectures Experience with Git/Version Control Excellent communication skills, proactive and self-sufficient, with strong organizational, time management and problem-solving skills Proven ability to break down and clearly define problems Passion for best quality practice and continuous professional development Experience with full lifecycle software development, the associated tools, processes and methodologies Solid experience in complex data management environments (e.g. SQL Server, T-SQL, NoSQL, Kafka, Elastic etc) Knowledge of OOP Design Patterns, Distributed Systems, Enterprise Application Integration, Service Oriented Architectures Excellent knowledge of HTML5, CSS3 and preprocessors (SCSS/LESS) and/or Tailwind Excellent knowledge of web standards, performance, accessibility Good knowledge of responsive web design methods Familiarity with modern front-end tooling (Webpack, esbuild) Our Preferred Qualifications: Exposure working with high-traffic public-facing websites Ability to articulate complex technical concepts in ways that can be understood by a variety of audiences Experience with container technologies, e.g. Docker, Kubernetes Expertise in creating public API’s / SDK’s DevOps and Continuous Integration and Continuous Delivery (CI/CD) knowledge Experience integrating with 3rd party API’s Alongside a base salary range of €36,000 to €49,000 we offer a range of benefits including: Health insurance and an Employee Assistance Programme Pension Annual Compensation Reviews Free monthly LetsGetChecked tests as we are not only focused on the well being of our patients but also the well being of our teams A referral bonus programme to reward you for helping us hire the best talent Internal Opportunities and Careers Clinics to help you progress your career within the company Maternity, Paternity, Parental and Wedding leave LetsGetChecked has a flexible annual leave policy Why LetsGetChecked At LetsGetChecked, we are revolutionizing healthcare by making it more accessible, convenient, and personalized. Our mission is to empower individuals with the knowledge and tools they need to manage their health proactively, so they can live longer, happier lives. By joining our team, you will be part of a dynamic and innovative company that is dedicated to improving lives through cutting-edge technology and compassionate care. We value our employees and invest in their growth, offering opportunities for professional development and career advancement. Together, we can make a meaningful impact on the future of healthcare and help people take control of their health journey. Join us in our commitment to transforming healthcare for the better. Our Commitment to Diversity, Equity, and Inclusion At LetsGetChecked, we are committed to fostering an inclusive environment that celebrates diversity in all its forms. We believe that the diversity of thought, background, and experience strengthens our teams and drives innovation. We are an equal-opportunity employer and do not discriminate on the basis of race, ethnicity, religion, color, place of birth, sex, gender identity or expression, sexual orientation, age, marital status, military service status, or disability status. Our goal is to ensure that everyone feels valued and empowered to thrive. #J-18808-Ljbffr
LetsGetChecked is a global healthcare solutions company that provides the tools to manage health from home through health testing, virtual care, genetic sequencing, and medication delivery for a wide range of health and wellness conditions. LetsGetChecked's end-to-end model includes manufacturing, logistics, lab analysis, physician support, and prescription fulfillment. Founded in 2015 and co-headquartered in Dublin and Atlanta, LetsGetChecked empowers people to take control of their health and live longer, happier lives. This is a great opportunity for someone looking to join a dynamic finance team in a fast-growing technology company. The successful candidate will work with different departments to help drive the company to an efficient payroll process as we continue to grow and expand as well as manage numerous office administrative tasks. Responsibilities and Duties: Manage accurate and timely processing of the end-to-end payroll cycle across multiple countries in the EMEA region, both in-house and utilising In Country Payroll Partners. Address and resolve any payroll related issues or discrepancies in a timely manner. Act as the first point of contact for regional queries. Partner with key internal stakeholders including Finance, Tax & Treasury. Perform month end journals and reconciliations. Ensure compliance with internal controls and local regulations. Identify opportunities for process improvements and assist with the implementation of new processes and systems. Serve as additional support for US Payroll. Complete ad-hoc tasks and other duties as assigned. What we are looking for ... 3 - 5 years experience in payroll processing multiple EMEA payrolls, specifically within countries of Spain, Portugal and other countries. Ability to manage multiple payrolls and deadlines while maintaining high accuracy. A recognised payroll qualification (IPASS, CIPP, CPP or equivalent). Experience with BrightPay and Payzaar is an advantage. Experience in fast paced, growth-stage technology companies. Advanced Microsoft office skills. Alongside a base salary of €45,000 - €50,000 we offer a range of benefits including: Health insurance and an Employee Assistance Programme Annual Compensation Reviews After 90 days you will be eligible to avail of Flexible Annual Leave where you are not restricted to a specific number of holiday days / annual leave Free monthly LetsGetChecked tests as we are not only focused on the well being of our patients but also the well being of our teams A referral bonus programme to reward you for helping us hire the best talent Internal Opportunities and Careers Clinics to help you progress your career within the company. Bike to work scheme - and secure bike storage onsite. Maternity, Paternity, Parental and Wedding leave. Why LetsGetChecked At LetsGetChecked, we are revolutionizing healthcare by making it more accessible, convenient, and personalized. Our mission is to empower individuals with the knowledge and tools they need to manage their health proactively, so they can live longer, happier lives. By joining our team, you will be part of a dynamic and innovative company that is dedicated to improving lives through cutting-edge technology and compassionate care. We value our employees and invest in their growth, offering opportunities for professional development and career advancement. Together, we can make a meaningful impact on the future of healthcare and help people take control of their health journey. Join us in our commitment to transforming healthcare for the better. Our Commitment to Diversity, Equity, and Inclusion At LetsGetChecked, we are committed to fostering an inclusive environment that celebrates diversity in all its forms. We believe that the diversity of thought, background, and experience strengthens our teams and drives innovation. We are an equal-opportunity employer and do not discriminate on the basis of race, ethnicity, religion, color, place of birth, sex, gender identity or expression, sexual orientation, age, marital status, military service status, or disability status. Our goal is to ensure that everyone feels valued and empowered to thrive. #J-18808-Ljbffr
LetsGetChecked is a global healthcare solutions company that provides the tools to manage health from home through health testing, virtual care, genetic sequencing, and medication delivery for a wide range of health and wellness conditions. LetsGetChecked's end-to-end model includes manufacturing, logistics, lab analysis, physician support, and prescription fulfillment. Founded in 2015 and co-headquartered in Dublin and Atlanta, LetsGetChecked empowers people to take control of their health and live longer, happier lives. Position Description: Research, develop and apply new innovative technologies to our healthcare products Be an advocate of state-of-the-art technology and engineering approaches Build new products and solutions that transform our industry Write clean, maintainable code using the best industry standards for mission-critical services Work with autonomy to find solutions to complex problems and be flexible and responsive to changing requirements and priorities Be a team member on a variety of projects including new product/component development, proofs of concept, and reengineering initiatives among others The ability for critical thinking outside your immediate sphere of responsibility Have experience with commercial products and environments (not just internally focused) Have a collaborative working style and contribute to the development of our technical communities across the company Requirements: BS or MS in Computer Science (or related technical discipline) or equivalent industry experience 3+ years as a full-stack developer Experience in geo-distributed Cloud environments (preferably AWS) Experience writing and maintaining automated tests to ensure code quality An understanding of RESTful architectures Experience with Git/Version Control Excellent communication skills, proactive and self-sufficient, with strong organizational, time management and problem-solving skills Proven ability to break down and clearly define problems Passion for best quality practice and continuous professional development Experience with full lifecycle software development, the associated tools, processes and methodologies Solid experience in complex data management environments (e.g. SQL Server, T-SQL, NoSQL, Kafka, Elastic etc) Knowledge of OOP Design Patterns, Distributed Systems, Enterprise Application Integration, Service Oriented Architectures Excellent knowledge of HTML5, CSS3 and preprocessors (SCSS/LESS) and/or Tailwind Excellent knowledge of web standards, performance, accessibility Good knowledge of responsive web design methods Familiarity with modern front-end tooling (Webpack, esbuild) Our Preferred Qualifications: Exposure working with high-traffic public-facing websites Ability to articulate complex technical concepts in ways that can be understood by a variety of audiences Experience with container technologies, e.g. Docker, Kubernetes Expertise in creating public API’s / SDK’s DevOps and Continuous Integration and Continuous Delivery (CI/CD) knowledge Experience integrating with 3rd party API’s Alongside a base salary range of €52,000 to €70,000 we offer a range of benefits including: Health insurance and an Employee Assistance Programme Pension Annual Compensation Reviews Free monthly LetsGetChecked tests as we are not only focused on the well being of our patients but also the well being of our teams A referral bonus programme to reward you for helping us hire the best talent Internal Opportunities and Careers Clinics to help you progress your career within the company Maternity, Paternity, Parental and Wedding leave LetsGetChecked has a flexible annual leave policy Why LetsGetChecked At LetsGetChecked, we are revolutionizing healthcare by making it more accessible, convenient, and personalized. Our mission is to empower individuals with the knowledge and tools they need to manage their health proactively, so they can live longer, happier lives. By joining our team, you will be part of a dynamic and innovative company that is dedicated to improving lives through cutting-edge technology and compassionate care. We value our employees and invest in their growth, offering opportunities for professional development and career advancement. Together, we can make a meaningful impact on the future of healthcare and help people take control of their health journey. Join us in our commitment to transforming healthcare for the better. Our Commitment to Diversity, Equity, and Inclusion At LetsGetChecked, we are committed to fostering an inclusive environment that celebrates diversity in all its forms. We believe that the diversity of thought, background, and experience strengthens our teams and drives innovation. We are an equal-opportunity employer and do not discriminate on the basis of race, ethnicity, religion, color, place of birth, sex, gender identity or expression, sexual orientation, age, marital status, military service status, or disability status. Our goal is to ensure that everyone feels valued and empowered to thrive. #J-18808-Ljbffr