Senior Regulatory Affairs Specialist Our client a high potential medical device start up current seeks a Senior Regulatroy Affairs Specialist to join their team. Reporting to the Director of Quality and Regulatory Affairs the Senior Regulatory Affairs will take an active role in developing the Regulatory strategy in Europe and the US and interacting with the relevant Regulatory and Notified Bodies. They will also be required to help maintain the Design History Fileof Class III implant. This position offers the opportunity to join in an exciting early stage company developing a novel cardiovascular device Role and responsibilities: Support the creation & maintenance of product design and technical documentation in compliance with the relevant regulations and standards (Class III, animal derived, implantable devices). This includes providing guidance to and coordinating inputs from the technical experts on each design project. Support the development and submission of high quality clinical and regulatory files to the relevant ethical committees and regulatory agencies, ensuring successful approval. Organise and maintain regulatory and clinical submissions with regulatory authorities, ethical committees, and clinical investigation sites. Co-ordinate and, where appropriate, conduct gap assessment activities in line with updated regulatory requirements and standards. Keep up to date with changes in applicable regulatory requirements and standards. Assist company preparation for inspection by notified body and regulatory authorities. Support implementation and maintenance of a robust and fully compliant quality system in accordance with ISO 13485, including risk management. Continuous improvement of the Quality Management System to meet the requirements of all stakeholders. Co-ordinate and progress Adverse Event reporting to regulatory authorities as required by QA/RA Director. Administrate the processes for the control of product information, including labelling, Instructions For Use (IFU), and user training. Ensuring adherence to all organisational and external regulatory requirements. Senior Regulatory Affairs Specialist Our client a high potential medical device start up current seeks a Senior Regulatroy Affairs Specialist to join their team. Reporting to the Director of Quality and Regulatory Affairs the Senior Regulatory Affairs will take an active role in developing the Regulatory strategy in Europe and the US and interacting with the relevant Regulatory and Notified Bodies. They will also be required to help maintain the Design History Fileof Class III implant. This position offers the opportunity to join in an exciting early stage company developing a novel cardiovascular device Role and responsibilities: Support the creation & maintenance of product design and technical documentation in compliance with the relevant regulations and standards (Class III, animal derived, implantable devices). This includes providing guidance to and coordinating inputs from the technical experts on each design project. Support the development and submission of high quality clinical and regulatory files to the relevant ethical committees and regulatory agencies, ensuring successful approval. Organise and maintain regulatory and clinical submissions with regulatory authorities, ethical committees, and clinical investigation sites. Co-ordinate and, where appropriate, conduct gap assessment activities in line with updated regulatory requirements and standards. Keep up to date with changes in applicable regulatory requirements and standards. Assist company preparation for inspection by notified body and regulatory authorities. Support implementation and maintenance of a robust and fully compliant quality system in accordance with ISO 13485, including risk management. Continuous improvement of the Quality Management System to meet the requirements of all stakeholders. Co-ordinate and progress Adverse Event reporting to regulatory authorities as required by QA/RA Director. Administrate the processes for the control of product information, including labelling, Instructions For Use (IFU), and user training. Ensuring adherence to all organisational and external regulatory requirements. Skills/Experience: Bachelor degree in science, engineering or related field Proven track record in a similar role with a minimum of 5 years in medical device Regulatory Affairs Extensive knowledge of quality management systems, design controls per ISO 13485 and current International and European regulations/standards with respect to medical devices. In depth knowledge of the EU Medical Device Directive and MEDDEV guidance documents Experience in design, verification and process validation processes Prior experience and knowledge in GMP, process validation, change control, CAPA and electronic document control systems Prior experience in class III medical products highly preferred Prior experience in a medical device start up preferred. Good leadership and project management skills with the ability and willingness to effectively build and manage a small team. Experience in people management and development. Excellent verbal and written communication skills For further information please contact James Cassidy james.cassidy@lifescience.ie or call 0860204322 #J-18808-Ljbffr
Senior Human Factors Engineer Reference: JCAO0112 Location: Dublin Qualification: Degree Experience: 4-5 Years Job Type: Permanent Salary: Not Disclosed Our client, a high potential start-up, is currently seeking a Senior Human Factors Engineer to join their team. Reporting to the R&D Director, the Senior Human Factors Engineer will be responsible for developing user requirements for devices. Role/Responsibilities: Lead the human factors process for a novel medical device, in compliance with internal procedures including EU and FDA requirements from design phase up through to production. Lead coordination of user studies. Develop and deliver project plans to performance, time, and cost targets. Lead the development of design and risk management documentation for human factors, including Market requirements, Design Specifications, Design Verification and Validation protocols, and reports. Act as the voice of the customer in product and user experience design for a novel medical device. Provide input into design reviews and identify potential design risks and develop appropriate risk mitigation plans. Support preparation of compliance packages for product evaluation/certification. Lead preparation of demos for user studies, company presentations, etc. Lead clinical studies involving the use of the developed products. Ensure full compliance with all Quality, Regulatory, Health and Safety, and other relevant legislation. Ensure full traceability of Design Development and control of changes. For further information, please contact James Cassidy at james.cassidy@lifescience.ie or call in confidence at 086 0204322. #J-18808-Ljbffr
We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Duties Oversee executionof the operational plan to ensure optimal productivity and reliable execution Lead team to ensure that all testing is completedon time, right first timeand to the required specification Optimize and reportkey performance indicators- quality, safety, productivity, on time delivery Ensure provision ofexcellent customer service, identifying and implementing continuous improvements in efficiency and service People management responsibility, includingcoaching, motivation, recognition, attendance management, training oversight, performance management, development planning and creating apositive team culture, enabling high engagement and retention. Continuous feedback and communication to and from the team Carry out testingin accordance with the valid testing procedures and regulatory requirements Work as part of the team ensuringcustomer expectations aremetand exceeded. Notify appropriate contact and document results and investigations for any atypical or aberrant results Lead Laboratory investigations and deviations if required We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Duties Oversee executionof the operational plan to ensure optimal productivity and reliable execution Lead team to ensure that all testing is completedon time, right first timeand to the required specification Optimize and reportkey performance indicators- quality, safety, productivity, on time delivery Ensure provision ofexcellent customer service, identifying and implementing continuous improvements in efficiency and service People management responsibility, includingcoaching, motivation, recognition, attendance management, training oversight, performance management, development planning and creating apositive team culture, enabling high engagement and retention. Continuous feedback and communication to and from the team Carry out testingin accordance with the valid testing procedures and regulatory requirements Work as part of the team ensuringcustomer expectations aremetand exceeded. Notify appropriate contact and document results and investigations for any atypical or aberrant results Lead Laboratory investigations and deviations if required Education & Experience Science graduate degree in Chemistry, Pharmacy or equivalent education/accreditation, coupled with a experiencein analytical testing, ideally within a pharmaceutical environment If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or sean.mccarthy@lifescience.ie for further information. #J-18808-Ljbffr
Our client, a leading global medical devices company, is now seeking a Chemist to join their team in Limerick. The primary function of this position is to lead and/or participate in projects focused on developing strategy with respect to chemistry, manufacturing, and controls (CMC) of combination drug devices, specifically providing oversight in method development and validation, compendial method verification and transfer, specification/acceptance criterion development, stability testing, out of specification (OOS) investigation, post-approval manufacturing changes, verification of active pharmaceutical ingredient (API) components to recognized compendial standards and API vendor qualifications and audit. This is very much a strategic, "desk-based" role, with a strong focus on process and problem solving. Our client operates a hybrid working model, so there is good flexibility in terms of the onsite requirement. Outline of Duties and Responsibilities: Maintain high level of expertise in FDA, US Pharmacopeia and/or European Pharmacopeia and ICH guidelines related to CMC regulatory topics. Provide oversight in the development of CMC strategies to support global regulatory strategy and submissions. Technically review data and reports for accuracy and consistency with regulator’s expectations (including, but not limited to stability data and lot release data such as HPLC, Particulate, Dissolution). Provide CMC expertise and collaborate with stakeholders to identify contract manufacturers, API vendor selection, qualification and support audits of same. Lead or participate in engineering projects serving as subject matter expert within the field of CMC and test method development. Provide input on new product introduction and assessing proposed manufacturing changes and provide guidance during implementation of product changes. Support the Investigation / Root Cause Analysis of OOS API results ensuring consistency in terms of methodology and regulatory expectations. Collaborate with other Post Market / Manufacturing Engineering Teams to ensure the effective completion of all activities associated with Post Market Engineering projects / objectives. Collaborate and interact effectively with other internal companies and global functions within the organisation (e.g., Regulatory Affairs, Engineering, Operations (Manufacturing), and Quality) to develop and implement CMC strategies. Ensure effective reporting to the Post Market Engineering management team. Work closely to build effective relationships with other functions in particular Production, Quality and Regulatory teams. Qualifications / Requirements: Bachelor’s degree, Masters or PhD is required, preferably in engineering/science or a related field. Minimum of 3 years’ relevant experience with CMC. Strong knowledge of medical device quality standards ISO13485/FDA practices and GMP, GLP or similar regulated industry standards. Familiarity with FDA, US Pharmacopeia and/or European Pharmacopeia and ICH CMC regulatory topics. Proven analytical and problem-solving skills. Strong interpersonal skills and the ability to communicate across functions. Familiarity with statistical methods, analysis, and interpretation. Ability to work on multiple projects, organize, and prioritize within time constraints. Familiarity with Microsoft Office software. High self-motivation. Willingness and availability to travel on company business. #J-18808-Ljbffr
Supply Chain Import / Export Specialist (Hybrid) Senior Associate Supply Chain Import/Export Specialist (Hybrid) RK3804 12 Months Dublin We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Duties: Ensures optimal internal and external customer satisfaction in line with company policies and procedures. Contributes to the completion of milestones associated with order management and specific projects or activities within the team or department related to order management. Supports and advises management on continuous improvement areas. Ensures distribution of pharmaceutical products globally; all orders are processed according to procedures and the customers' requirements. Identifies potential issues and implements proactive solutions. Escalates to Management when (potential) issues cannot be solved by the team. Initiates and executes improvements in order to increase effectiveness and efficiency of order management performance. Contributes as a project team member for overall order management related projects. Reviews monthly KPI reporting and advises on issues to be elevated and discussed during GSHE monthly metric meetings. Ensures knowledge of GMP/GDP and job-related training is up to date for SC I/E team. Ownership and generation of order management controlled documents as needed. Participates in ABR internal and external audits as needed. Provides input for month-end closing as needed. Applies order management SME knowledge in SC I/E related projects and implementation of new processes or process changes. Conveys proactive solutions to problems and timely escalation if needed. Establishes working relationships with others outside area of expertise. Ensures that our internal and external customers are taken care of according to the company's policies and procedures. Ensures that all orders are processed according to the customers’ specific instructions and conditions. Education and Experience: Bachelor’s degree or equivalent in Supply Chain Management or Logistics. Typically 3 or more years of Supply Chain experience in a GMP and/or GDP regulated industry. Knowledge and experience with SAP. Experience managing stakeholders. If interested in this posting, please feel free to contact Rachel Kent at Life Science Recruitment for further information. #J-18808-Ljbffr
Job title: Project Manager - R&D Location: Ballybrit, Galway Benefits: Excellent salary, bonus, pension, healthcare, hybrid working and opportunity to grow your career with a hugely exciting Medical Device organisation. Company: My client is a Medical Device company who has recently been acquired by a multinational, a global leader in neurovascular care, with a broad portfolio of devices used in the endovascular treatment of hemorrhagic and ischemic stroke. My client invests in their people and takes great pride in providing a positive work environment that respects diversity, supports wellbeing, and embraces innovation. About the role: The Research & Development Project Manager will be part of the R&D team in Galway, an exciting group of engineers and scientists dedicated to understanding unmet needs in neurovascular diseases (such as stroke) and developing innovative device solutions to improve their treatment. Some responsibilities include: Provide technical leadership and take ownership of critical technical tasks in the execution of new product development catheter projects. Liaise with key opinion leaders to develop a deep understanding of the disease state, gather user needs, and articulate throughout the team. Translate needs requirements into technical specifications. Foster a culture of creativity; generate creative product solutions to address unmet needs. Provide leadership to the team in the development of test models for prototype performance evaluations, building and testing of prototypes, test data analysis and interpretation, component and finished device assembly drawings/specifications, product materials selection, and process development. Hands-on approach where appropriate, leading critical activities by example. Identify and manage key technical risks and appropriate mitigations throughout the product lifecycle. Program Management Responsibilities: Develop detailed technical project goals, plans, and budget. Identify critical project tasks, define project strategy, and set team priorities. Identify and manage key program risks. Manage direct team and across functions to deliver on performance, time, and cost targets. Report progress across the organisation. Leverage and liaise with external resources to achieve project goals. Manage project in accordance with quality system – take ownership of design history file and lead design reviews. Requirements: A minimum of 8 years’ experience in the medical device industry with experience of technical project leadership, and prior catheter product development experience as a Senior R&D Engineer is required. Strong technical leadership capability, responsible for leading and managing the technical team in the development of differentiated catheter devices. Strong catheter design, development, and technical ability is essential, based on a solid foundation of fundamental engineering principles. Strong work ethic and creative problem solver. What awaits you: An opportunity to work with a ground-breaking biomedical operation, part of a company with an excellent record in employee continuous professional development and business improvement. An opportunity to be part of a global market leader. A dynamic and inspiring working environment. Opportunities to work on challenging projects and assignments. Possibilities for further personal and professional development/education. Excellent benefits. Does this sound like your next career move? To apply and for more info, forward your application to the link provided or contact me at 087 0612325 or thomas.gallagher@lifescience.ie. #J-18808-Ljbffr
11 Month contract On-site Cork Shift role 5/2 AMC22465 I am looking for several Quality System specialists to join a growing team in a leading Pharmaceutical manufacturer in Cork. If you have 5+ years experience in QA roles in Pharmaceutical manufacturing with an in-depth knowledge of Quality Systems, this could be the role for you! In this role, you will provide Quality oversight, support, and knowledge to activities relating to Quality Systems across the site and in meeting the company priorities of: Compliance, Supply, Strategy, and Profit Plan. The role is a shift, full-time onsite role providing quality oversight to Operational areas on site. This role is integrated into the production area. The shift is 5/2, week 1 is M/T/F/S/S all 11-hour days. Week 2 is W/T 11.30 hr days. Primary Responsibilities: Provide expertise in Quality Systems and Operational Quality (e.g., Quality Notifications, Investigations, Change Management, environmental monitoring, sterility assurance). Lead continuous improvement initiatives, resolve complex issues, and execute tasks. Act as a resource for colleagues, guiding on Quality Systems and compliance requirements. Ensure regulatory compliance and remain up to date with evolving standards. Oversee and approve commissioning/qualification activities (IQ/OQ/PQ). Identify solutions to non-standard requests, ensuring decisions align with policies and impact quality, projects, and systems. Support Corporate Quality in executing site-related Quality System actions. Contribute to inspections, GMP walkthroughs, deviation management, and change control approvals. Drive high product quality and compliance standards through the Quality Management System. Lead small projects, coach colleagues, and manage stakeholder relationships. Maintain safety standards and assist with other tasks as assigned by the QA Lead. Requirements: Degree or equivalent qualification in Science or Quality. 5+ years’ experience in the pharmaceutical/chemical manufacturing industry in Quality Assurance roles. In-depth knowledge of regulatory requirements and Quality Systems. Proven ability to work independently, lead projects, and coach teams. Advanced PC skills (Excel, Word, PowerPoint) and strong problem-solving abilities. Exceptional communication, decision-making, and stakeholder management skills. Energetic and proactive with a commitment to maintaining the highest standards of quality and compliance. Apply today or get in touch with Angela McCauley in Life Science Recruitment for more information. #J-18808-Ljbffr
Job Title: Advanced Technologies R&D Manager Location: Ballybrit, Galway Benefits: Competitive salary, 13% yearly bonus, share options, pension, and healthcare. Company: My client is an emerging leader in Neurovascular care in the Medical Device industry. Located in a European hub for the Medical Device industry, my client works closely with physicians from around the world to develop devices used in the endovascular treatment of strokes. Role: As an Advanced Technologies R&D Manager, you will be responsible for providing technical leadership in prototyping and early process development, test lab operations, and be an integral part of the design and development of their technologies. In 2025, exciting expansions in their prototyping lab space and testing capability will need to be managed in terms of prototype line setups, equipment identification, and qualification. This role will manage the efficient operation of all test labs, concept and GxP testing, and EH&S requirements. The Advanced Technologies R&D Manager will support new project development (NPD). Key Responsibilities: Lead prototype and lab engineers/technicians for equipment commissioning, validations, maintenance, calibration, and process development studies. Manage technical project resources as required, including responsibility for goal setting, performance reviews, and identifying and supporting development needs. Provide leadership to wider R&D teams in the development of new processes, building and testing of prototypes, testing, data analysis and interpretation, component and finished device assembly drawings/specifications, product materials selection, and process development. Ensure test labs are GxP compliant in terms of equipment, fixtures, and daily operations. Assessment of current and emerging process technologies for suitability for application to the development of interventional medical devices, including catheters and delivery systems. Develop expert knowledge on emerging technologies to support implementation and adoption into the wider organization. Be the subject matter expert and provide technical leadership for all activities related to early-stage prototype and process development to influence the design team on concept and design development. Qualifications Required: Qualification in Mechanical or Biomedical Engineering or equivalent. Manufacturing/Process development experience. Project management qualification is an advantage. Significant experience in the interventional medical device industry with experience of technical leadership and prior product development experience. If you have a background in Manufacturing and are looking to move more into the R&D side of the business, please contact me at 087 0612325 or email Thomas.gallagher@lifescience.ie. #J-18808-Ljbffr
Senior Director Statistics Data and Analytics Senior Director Statistics, Data and Analytics Our client, a global pharma company, is adding to their statistics team and is currently recruiting for a Senior Director Statistics, Data and Analytics to join their talented team, on a permanent basis. People management experience is essential for this role. This role provides hybrid working. Responsibilities: Provide strategic leadership to all the assets within the portfolio under the following areas: Discovery & Development (i.e., non-clinical), Immunology, Diabetes and Complications, Neuroscience, CM&C or Oncology, Advanced Analytics and Access. Provide overall leadership including supervision, mentoring/coaching, career development, and performance management for statisticians, statistical analysts, and data management of the respective area. Accountable for recruiting, identifying & retaining top talent, and managing performance to ensure therapeutic area/discovery & development and functional success. Collaborate with Operations Leader to ensure appropriate operational support. Provide scientific leadership and coaching at both a strategic and tactical level. Oversee management of product portfolios development and post-launch activities including assignment and allocation of Statistics and Statistical Analysts resources. Communicate and contract with infrastructure partners (e.g., Information Technology regulatory, scientific communications, Clinical Operations, and Intelligent Automation). Ensure compliance with internal and external standards and SOPs. Provide consulting and coaching to product Statistics and Statistical Analysts personnel to ensure that appropriate product AA strategies are developed and delivered by global strategy. Ensure that input is provided for molecule development teams for completion of AA evaluation as per global strategy. Review the technical computing platform and align with global strategy for readiness and participate in pilots for potential early adaptation. Engage therapeutic area platform and other regional leaders and thought leaders to understand customer needs and help drive strategy. Contribute as appropriate to regulatory strategy, clinical plans, protocol designs, analysis plans, data flow, and disclosures for studies. Accountable for major study design elements for key studies for a brand/molecule. Ensure collaboration between statistics and data management, medical, regulatory, Observational and Medical Affairs, and other regions occurs and recommend appropriate clinical trial designs. Ensure appropriate opportunities are available to engage and contribute to innovative designs and implementation to enhance overall efficiency. Requirements: Ph.D. in Statistics or Biostatistics with at least 5 years of experience in Drug Research and Development. Minimum of 3 years of Management or Leadership Experience. Experience in managing clinical data and understanding drug development, approval, and launch processes. Ability to manage a large portfolio and experience managing people. Ability to communicate effectively and influence within the organization. Depth in one or more research disciplines. Ability to inspire and set strategic direction. Ability to manage for results. Operates well across boundaries. Excellent written and verbal communication skills. Excellent interpersonal and negotiation skills. Established record of successfully developing employees. Ability to develop local excellence with a global mindset. For more information contact Sinéad Cullen on +353879500821 or sinead.cullen@lifescience.ie #J-18808-Ljbffr
Job title: R&D Technician II Location: Ballybrit Upper Industrial Estate, Galway Benefits: Top salary, Pension, healthcare, yearly bonus, Hybrid working and the option of a 4 day week. Company: My client is a global leader in the medical device industry and expert in the design, development, and manufacturing of complex medical devices and component technologies. Role: As an R&D Technician, you will provide technical support to engineers in set-up and calibration tasks, as well as performing rework and quality testing related to the production of parts, components, subassemblies, and final assemblies. You will develop and recommend procedures and methods, and prepare technical reports and documentation. Additionally, you will perform technical evaluations of events to determine root cause and recommend corrective action. Responsibilities: Design & develop delivery systems for client companies. Assemble, test & package complex mechanical devices following written & verbal instructions. Work with Engineers to design & develop assembly methods. Maintain accurate work records such as engineering notebooks and routers. Train assemblers, technicians, & engineers in assembly methods. Maintain accurate inventory records. Assist with in-process testing to assure product meets specifications. Skills and Qualifications: Technical Diploma advantageous. 1 year experience in the Medical Device industry. Balloon Catheter development or manufacturing experience desirable. Does this sound like your next career move? For more info, forward your application or contact me at 087 0612325 or thomas.gallagher@lifescience.ie. #J-18808-Ljbffr
