Why Join Us About Cook Medical Since 1963, Cook Medical has been finding solutions to improve the world's healthcare problems for the patients and doctors we serve. As the world's largest privately owned medical device company, we have always operated with our patients, customers, employees and communities at our core. We do this, not only because it is good business, but also because we believe that exemplary patient care and being a good corporate citizen is the right thing to do. Cook Medical has been in Limerick since 1996, starting out with labelling and distribution and steadily growing and evolving to include manufacturing, centralised customer support and on to collaborative product development in the Innovation Centre. The Ireland location is our European headquarters and houses our EMEA Support Centre. This location currently employs more than 1000 people and manufactures 10% of Cook's products for global markets. Overview The Opportunity Start and Grow your Career through an Inclusive Employment Partnership*. Cook Medical are partnering with the Rehab Group and the National Learning Network to provide opportunities for a 16 week paid internship. These internships will commence in September with Cook Medical. *This program is only available to third level graduates with a disability (e.g physical, mental health, specific learning disability, etc.) Responsibilities We currently have placement opportunities in the following departments:- Customer Support and Delivery Human Resources IT Facilities Finance Manufacturing Engineering Regulatory Affairs Quality Assurance Mentoring and training will be provided. Qualifications Third level qualification in a relevant discipline is required. A genuine interest in gaining Industry experience. Strong work ethic. Highly motivated individual, self-starter with a passion for excellence. *This program is only available to third level graduates with a disability (e.g physical, mental health, specific learning disability, etc.) #LI-Hybrid To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
Overview The Customer Support Representative 1 is responsible for providing a professional, friendly, and efficient service to Cook Medical customers and Divisional Sales teams throughout EMEA. Key tasks include handling customer orders accurately and within agreed service levels, while also providing timely and informative responses to customer queries. To be successful in this role, you should be an excellent communicator who gains and builds trust during all interactions who will add to our reputation as a company who offers excellent customer service. Reports to: Team Lead 1, Customer Support Responsibilities Process all orders and other customer transactions accurately through relevant company systems within department guidelines and Quality requirements. Process all queries within department guidelines through relevant company systems. Process product complaints through relevant company systems and within the required timelines. Liaise with relevant courier companies and / or relevant internal teams as needed to ensure prompt delivery to all customers. Manage urgent and / or emergency orders / requests as they arise and communicate to the relevant teams, manufacturing plants, etc., seeking advice of more experienced colleagues as required. Log all internal and external customer feedback correctly and on time, promote the Customer Portal when possible. Maintain and update customer data as required. Liaise with Cook Medical field-based sales teams, Field based Inventory team and Supply Chain Operations teams to ensure fastest possible turnaround on all inventory, inventory returns and resolution of any inventory issues that may occur. Complete all training assigned in a timely manner to ensure required level of competence for this role and to maintain audit compliance. Take on additional tasks and involvement in the execution of new departmental projects / initiatives as trained / required. Consistently display a positive attitude towards customers and colleagues, treating everyone in a professional manner and with respect. Always ensure a high level of customer support to all customers, taking ownership for first point of contact resolution wherever possible. Maintain a supportive and communicative relationship within direct and wider teams at all times. Carry out all tasks in compliance with the Company's Quality Management Systems. Qualifications 1 to 2 years' experience in a multi-national customer support / contact centre environment advantageous. Fluency in Spanish and English. Good written and spoken English language skills for those Representatives for whom English is not their mother language. Excellent telephone manner and interpersonal skills. Good working knowledge of Microsoft Office. Attention to detail, accuracy and ability to multitask. Ability to work under pressure and on own initiative with a positive attitude to problem-solving. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
Overview The Customer Support Representative 1 is responsible for providing a professional, friendly, and efficient service to Cook Medical customers and Divisional Sales teams throughout EMEA. Key tasks include handling customer orders accurately and within agreed service levels, while also providing timely and informative responses to customer queries. To be successful in this role, you should be an excellent communicator who gains and builds trust during all interactions who will add to our reputation as a company who offers excellent customer service. Reports to: Team Lead 1, Customer Support Responsibilities rocess all orders and other customer transactions accurately through relevant company systems within department guidelines and Quality requirements. Process all queries within department guidelines through relevant company systems. Process product complaints through relevant company systems and within the required timelines. Liaise with relevant courier companies and / or relevant internal teams as needed to ensure prompt delivery to all customers. Manage urgent and / or emergency orders / requests as they arise and communicate to the relevant teams, manufacturing plants, etc., seeking advice of more experienced colleagues as required. Log all internal and external customer feedback correctly and on time, promote the Customer Portal when possible. Maintain and update customer data as required. Liaise with Cook Medical field-based sales teams, Field based Inventory team and Supply Chain Operations teams to ensure fastest possible turnaround on all inventory, inventory returns and resolution of any inventory issues that may occur. Complete all training assigned in a timely manner to ensure required level of competence for this role and to maintain audit compliance. Take on additional tasks and involvement in the execution of new departmental projects / initiatives as trained / required. Consistently display a positive attitude towards customers and colleagues, treating everyone in a professional manner and with respect. Always ensure a high level of customer support to all customers, taking ownership for first point of contact resolution wherever possible. Maintain a supportive and communicative relationship within direct and wider teams at all times. Carry out all tasks in compliance with the Company's Quality Management Systems. Qualifications 1 to 2 years' experience in a multi-national customer support / contact centre environment advantageous. Fluency Dutch and English. Good written and spoken English language skills for those Representatives for whom English is not their mother language. Excellent telephone manner and interpersonal skills. Good working knowledge of Microsoft Office. Attention to detail, accuracy and ability to multitask. Ability to work under pressure and on own initiative with a positive attitude to problem-solving. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
Overview IP Strategy Manager will develop, implement, & manage patent strategy for selected businesses via collaboration w/R&D, Business, & Legal teams to support the commercial needs of Cook. Collaborative activities include: disclosure & application reviews, prosecution & filing decisions, portfolio analyses, monitoring competitive IP landscapes, & may include support of related activities such as evaluation of licensing opportunities, infringement analyses, & litigation. This is a hybrid role that includes occasional on-site work, open to candidates based in the following locations: P48, CRI, Cook Spencer, Cook Winston-Salem, Cook Advanced Technologies, Cook Ireland, William Cook Europe-Denmark. Responsibilities Within selected therapies/specialties, lead the development of global intellectual property strategies & support the management of Cook's portfolio of patents, trade secrets, & technical know-how while balancing costs. Coordinate regular cross-functional decision-making for routine IP management via both monthly IP Committee meetings as well as e-mail, including input on agenda content, provision of succinct analyses, summaries, & recommendations, & communication with IP counsel. Collaborate with engineers in harvesting new inventions: brainstorm, identify inventions, & provide input upon the preparation of disclosures. Review disclosures and engage patent committees, legal teams, and product development members in making strategic decisions on IP coverage. Review summaries of prior art searches and work with Legal to evaluate the patentability of inventions. Utilize IP Management System software to maintain IP coverage information for products & up to date IP summaries for R&D projects. Lead & participate in initiatives to increase quantity/quality of Cook's IP. In collaboration w/R&D, Business, & Legal teams: develop, communicate, update, & otherwise maintain IP strategies for selected product/technology areas. Conduct competitive intelligence programs by monitoring IP filings, product announcements, & technical literature for input into IP strategies. Conduct and/or obtain relevant IP landscape information, Prepare IP portfolio overviews & identify significant gaps as well as unwanted IP that may be considered for out-licensing or divestiture. Support patent Infringement investigations, as required. Train employees on invention disclosures & IP protection. Maintain high level of awareness & application of relevant industry standards. Qualifications Education and/or Work Experience Qualifications Required Bachelor's degree in Marketing, Electrical, Mechanical, Chemical, or Biomedical Engineering or related scientific or legal discipline Five years' experience developing and/or managing products or Intellectual Property in any competitive environment Preferred Experience developing and/or managing products in a Medical Device R&D environment, including direct experience with related Intellectual Property Knowledge, Skills, and Abilities Required Ability to review and analyze technically complex documents, including scientific papers, patents, and technical specifications. Excellent analytical, interpersonal, verbal and written communication skills. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
Overview We have an exciting opportunity for an experienced health economics and value professional who wants to directly lead, shape and grow Cook Medical's global value-based healthcare and health economic agenda, working closely with Global Health Economics leadership to drive change and adoption company-wide. As part of our expanding Health Economics team, this role will focus on market access by shaping projects and creating user-friendly health economic models and value tools, in partnership with commercial and functional teams. This role will collaborate with and advise peers and internal stakeholders on clinical/health economic studies, and identification and development of new business opportunities. The successful candidate will: Demonstrate strong communication, collaboration, and project management skills. Have an analytical mindset and data-based approach to create clear concise value tools, translating value claims into quantitative/health-economic models. Enjoy being challenged by finding the value story behind the existing data and is comfortable challenging the status quo to drive new processes forward. Thrive working autonomously, be confident in making decisions to ensure timely project progression and focus on producing key impactful deliverables to support health economic and value conversations. Possess these capabilities: Produce insightful visualizations of large data sets Translate complex technical and clinical data in an easily digestible and interesting manner. Lead change at all levels Responsible for managing market access programs, projects and creation of user-friendly health economic models and value tools, with a deployment to external customers while partnering with relevant teams, in alignment with Division and specialty goals, priorities and overall company strategy and vision. Collaborate with, advise and influence peers and company stakeholders on clinical/health economic studies, and identify and contribute to the development of new business opportunities. Responsibilities Collaborate closely with the divisions and other company functions to advance the market access strategy for new and existing technologies that align division and company goals and strategies. Develop economic value propositions and communicate the value messaging through bespoke business cases, value tools, training materials and summary sheets to support commercial, business and reimbursement discussions with decision-makers. Create and utilize different health economics models (i.e. budget impact models, cost-effectiveness models) to communicate the public health impact and economic value of Cook technologies to clinical and non-clinical stakeholders, such as payers and providers. Use previous experience to offer moderate improvements on existing processes and practices in line with value-based healthcare agenda to support future growth of Cook. Support all stages of product development by actively engaging in evidence strategy development, acting as value expert in early value proposition development, providing early health economic models and compiling burden of disease reviews and adapting information according to global market needs. Interact regularly and effectively with external customers (SME's, medical societies, and other key national and regional stakeholders) to assist with describing the value proposition and models. Develop new external stakeholder relationships to understand needs and explore partnership opportunities. May provide guidance and coaching and training to other employees across the Company, and directly with customers, within area of health economics and product value propositions. Provide commercial support (e.g., training regional teams, engaging customers directly) as needed to drive business results and serve as day-to-day support on health economics matters for various teams. Execute and manage projects with academia, external collaborators and vendors to ensure timely completion and quality of deliverables as well as budget and legal compliance Partner with business leadership to ensure health economic and value activities align with and support commercial objectives. Monitor, analyze and communicate relevant developments in health technology assessments (HTA) and value-based healthcare for assigned countries. Adapt current health economic tools for wider global adoption in collaboration with company stakeholders. Meet deadlines and complete administrative tasks such as expenses, training, reporting, policy acknowledgements, etc. in a timely manner. Understand and be accountable for conducting Cook business with integrity and in compliance with applicable standards including Cook policies. Within scope of responsibility, ensure all quality, regulatory, compliance and product-specific requirements are met. Qualifications Required Experience: Minimum 7 years relevant experience, including health economics, market access, and/or reimbursement. Prior experience and deep knowledge in health economic modelling and creating value messaging and support tools. Demonstrated ability to work effectively autonomously as well as in teams. Broad project management skills with experience prioritizing and managing large/complex and simultaneous projects to completion. Excellent communication skills (writing and verbal) with strong ability to communicate complex concepts in a simple and engaging manner Prior experience presenting to leadership and external audiences. Demonstrated ability to create structure within ambiguity. Demonstrated strong relationship building skills. Proficient in Microsoft Office with advanced Excel skills in modelling and analysis. Preferred Qualification: Advanced graduate degree (Ph. D. or master's degree) in health economics or related field. Health economics, market access, and/or reimbursement experience in Medical Device or pharmaceutical industry. Demonstrate positive and constructive behaviors that drive team cooperation in achieving objectives. Experienced in providing coaching, guidance and training to other employees Demonstrate excellent leadership and presentations skills. Excels in a highly collaborative team setting. Demonstrate the ability to think strategically. Physical Requirements/Work Environment: Ability to travel as needed. Work under general office environmental conditions Other Requirements: Employee signs a non-competition and confidentiality agreements in relation to his/her employment with Cook. Employee acts in compliance with company policies including but not limited to, the Cook Employee Manual, Cook Code of Conduct, Cook Electronic Information Policy, Product Complaints, HIPAA regulations and Cook Policy & Guidance On Interaction with Healthcare Professionals. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
Overview The Post Market Specialist serves as a communication liaison between the Cook manufacturer and the Cook local affiliates or regulatory authorities and assists in assessing complaints for Regulatory Reporting, this includes Adverse Event Reporting (MDR, Vigilance, etc.), Post Market Surveillance Activities (PMS), field action and associated correspondence to applicable Regulatory bodies. Reporting to: Team Lead, Post Market Surveillance Find out more about Cook Medical here Responsibilities Assess complaints from Cook global customer support and delivery centres for adequate information to determine if event meets Regulatory Reporting requirements. Utilize appropriate complaint software systems for processing complaints to/from customer support and delivery centres and QE Investigation functions. Generate appropriate regulatory reports based on assessment. Liaise effectively with regulators on all issues with regard to regulatory reporting. Ensuring that confirmed reportable events are escalated to the appropriate personnel in a timely manner. Communicate with other Cook Companies globally as necessary for reporting. Generate responses to inquiries on AE reports from various global regulatory authorities. Generate various reports, including but not limited to, Regulatory requests, Marketing requests, Engineering requests. Input into the assessment of field action through the Health Risk Assessment process. Assist in coordination of Field Action administration activities between manufacturer and distribution centre. Close out of complaints as necessary. Input and adherence to the scheduling and management of Post Market Surveillance (PMS) plans and reports. Maintains appropriate regulatory records to demonstrate compliance with applicable regulations. Maintain an excellent understanding of global medical device regulations. Knowledge of relevant ISO, EU, FDA medical device standards regulations is required. Coordinates multiple projects at one time and provides regular reports to regulatory management and others as required. Serves as a liaison on regulatory issues between the Cook Manufacturer and the Cook International local office and/or Cook distribution partner. Maintains and organises appropriate regulatory records to demonstrate compliance with applicable regulations. Performs additional duties as assigned. Ensure that Cook's Code of Conduct is considered in all business matters carried out on Cook's behalf. Delegate for the Regulatory Communications Team Lead. Qualifications Third level Qualification in Science/Engineering desired. Experience in a regulated industry ( ideally minimum 1 years) in a similar role is required. Thorough knowledge of the EU & US medical device regulatory requirements. Knowledge of regulatory requirements in MDSAP countries. Desirable to have knowledge of requirements in other jurisdictions. Knowledge of medical device quality standards/practises or similar regulated industry. Good communication and inter-personal skills. Proven problem-solving skills. Good computer skills including knowledge of Microsoft Office. Proven organisational skills. High self-motivation. Willingness and availability to travel on company business. About Cook Limerick Cook Medical has been in Limerick since 1996, starting out with labeling and distribution and steadily growing and evolving to include manufacturing, centralised customer support and on to collaborative product development in the Innovation Centre. The Ireland location is our European headquarters and houses our EMEA Support Centre. This location currently employs more than 1000 people and manufactures 10% of Cook's products for global markets. Quality Engineering in Limerick Our QE team in Limerick is made up of 4 different subgroups: quality engineering, supplier engineering, regulatory communications and complaint investigations. The quality engineering team are responsible for the CAPA, NCR, NC trending and field action assessments processes. They work cross functionality with operations, engineering, medical affairs and regulatory affairs during the design process and throughout the device lifecycle. They are heavily involved in supporting strategic objectives for the site including IT solutions and continuous improvement efforts. The supplier quality engineering team are responsible for the qualification, auditing, monitoring and assessment of all new and existing suppliers across this site. This ranges from quality impacting suppliers to non-quality impacting suppliers. The regulatory communications team are responsible for the regulatory assessment and submitting reports as required for all our device customer complaints. In addition, they are responsible for any field actions which are initiated associated with Cook Ireland manufactured devices as well as monitoring and implementing changes associated with regulatory intelligence and are a key input into the post market surveillance programme. The complaint investigations team are responsible for the root cause, evaluation, investigation, risk assessment and corrective action determination of all our device related customer complaints. They are responsible for the evaluation of any returned medical devices from the field in a biohazard laboratory. The complaint investigation team are also responsible for trending assessments and are a key input into the post market surveillance programme. Even though these teams are distinctively different in terms of roles and responsibilities, they are all intertwined as they are responsible for different aspects of the product lifecycle which ultimately all feed into one another. Our Quality Engineering team are central to holding Cook to the highest standards because everything we do has an impact on someone's life. Our employee benefits include: Hybrid Work Model Company sponsored Defined Contribution pension scheme Medical Health Insurance cover for you and your immediate family Life Assurance and Income Protection cover Educational Assistance Performance related Bonus Extensive health & wellness program including Indian head massages, healthy lifestyle seminars, mindfulness courses, physio sessions, flu vaccinations, nutrition talks Fully equipped gym on site 39-hour week with flexible start & finish times Paid time off to participate in volunteer activities Free parking Subsidised restaurant Sports & Social club #LI-Hybrid To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
Overview Cook is a privately owned, global company that has been, for over 60 years, inventing, manufacturing, and delivering a unique portfolio of medical devices to the healthcare systems of the world. Our Global Legal team is a diverse and dynamic team of attorneys who support the organization's business functions located worldwide. Each member of the team has unique responsibilities and expertise, but every member shares the common objective of supporting Cook's relentless pursuit of inventive solutions to help our customers, patients, and communities thrive. We are seeking an experienced Senior Attorney, Global Ethics & Compliance to join our Global Legal team full-time. This position will be a hybrid position with expectation to attend the Cook offices in Limerick, Ireland 1 to 3 days a week. At Cook, it is our company culture to be open to different ideas and perspectives and be appreciative of each person's contributions. We want to create opportunities for talented individuals who will contribute positively to the company. We are looking for the best candidate for the Senior Attorney role and invite those to apply who can bring their unique perspective to our team. Overview: The Senior Attorney, Global Ethics & Compliance is primarily responsible for providing strategic legal advice in respect of Cook's Global Ethics and Compliance ("E&C") program in a manner consistent with the company's business philosophy and strategy and in compliance with legal and regulatory requirements. Responsibilities Essential Duties and Responsibilities Reporting to the Director and Corporate Counsel, Global Ethics and Compliance, the Senior Attorney, Global Ethics & Compliance responsibilities include the following: Provide strategic guidance in respect of Cook's Global E&C Programs that reflects a deep understanding of the global legal and business environment. Identify and mitigate risks by researching and providing advice on complex legal and commercial compliance issues, developing resolutions to identified risks, and exercising considerable judgment in proposing alternative solutions. Stay updated on relevant law, regulations, and evolving developments; providing strategic, accurate, high quality and practical legal advice to management and other attorneys and recommending policy and/or process changes as needed. Review, input and provide legal sign off on internal policies, procedures and guidance. Legal stakeholder in projects across the Cook business. Identify skills gaps and lead efforts to build legal and compliance capabilities across Cook. Act as an investigative authority to direct sensitive/complex privileged investigations on behalf of the law department. Manage the appointment and engagement of external counsel including managing reasonable budgets and delivering results within those budgets. Partner collaboratively and cross-functionally with various teams effectively and professionally through various levels of the global organization and ensure leadership of the law department and company is properly and timely informed about legal issues and risks facing the business. Engage with key external collaborators, including counterparts at other companies in the industry, trade associations, and outside counsel networks, to understand the current legal and business environment, identify trends and ensure legal policy interests are aligned and advanced. Develop, support, and participate in the development of processes, policies and procedures within and for the global legal function. Develop, support, and participate in the development of legal initiatives to enhance legal service delivery, efficiency and innovation. Ensure that Cooks Code of Conduct is considered in all business matters conducted on Cook Medical's behalf. Qualifications Education and/or Work Experience Qualifications 10+ years of experience, preferably a portion of which took place at a major law firm, government, in-house or a combination Deep knowledge of global compliance frameworks with a particular emphasis on US compliance frameworks including the Foreign Corrupt Practices Act; global anti-bribery laws; US healthcare compliance laws such as the Anti-Kick-Back Statute, False Claims Act and Sunshine Act; Department of Justice and Office of Inspector General guidance and enforcement trends. Experience working within medical device, pharma, healthcare, or other highly regulated industry Professional legal qualification with an active license to practice law in the United States or Ireland. Knowledge, Skills, and Abilities Excellent understanding of regulatory environment and legal frameworks within the medical device industry, in addition to all applicable ethics and compliance standards. An articulate, motivated & proactive individual with a track record of developing strong working relationships within an energetic environment. Ability to establish and maintain effective relationships with others, whether internal or external to the organization, and throughout various levels of the global organization. Manage conflict in a way that recognizes and manages differing opinions and ideas and refocuses them in a positive and constructive manner. Ability to work across teams and manage multiple priorities to accomplish multiple tasks in a timely and cost-efficient manner. Foster and maintain a workplace culture respectful and supportive of individual differences. Remain calm and receptive in fast paced situations. Maintain the highest level of confidentiality and integrity. Maintain company quality and quantity standards and foster a culture of continuous improvement. Have excellent problem-solving skills and an ability to work in collaborative and independent work situations and environments with minimal supervision. Strictly adhere to safety requirements. Maintain regular and punctual attendance. Comply with the rules of professional conduct for attorneys, as required by the geography of licensure, accreditation, or certification. Ability to learn and actively role model the Cook Values, and a desire to make an impact as part of a company that is Relentlessly Inventive and Deeply Connected. Strong verbal & written communication. About Cook Limerick Cook Medical has been in Limerick since 1996, starting out with labelling and distribution and steadily growing and evolving to include manufacturing, centralised customer support and on to collaborative product development in the Innovation Centre. The Ireland location is our European headquarters and houses our EMEA Support Centre. This location currently employs more than 1000 people and manufactures 10% of Cook's products for global markets. Our employee benefits include: Hybrid Work Model Company sponsored Defined Contribution pension scheme Medical Health Insurance cover for you and your immediate family Life Assurance and Income Protection cover Educational Assistance Performance related Bonus Extensive health & wellness program including Indian head massages, healthy lifestyle seminars, mindfulness courses, physio sessions, flu vaccinations, nutrition talks Fully equipped gym on site 39-hour week with flexible start & finish times Paid time off to participate in volunteer activities Free parking Subsidised restaurant Sports & Social club #LI-Hybrid To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
Overview The HR Business Partner is a strategic partner to the Divisions in operational matters, such as organization structure, general business plans, succession planning, employee effectiveness, headcount utilization and compensation planning. This position serves as a consultant to leadership on human resource-related issues. Reporting to: Director, Human Resources, Field Based Employees EMEA Responsibilities Partners across functions to deliver value-added service to leadership and employees that reflects the business objectives of the organization, developing strategic relationships with internal and external stakeholders. Strive for continuous improvement in HR and throughout the business . Supports Cook employees on human resource matters or queries they may have and facilitates actions to resolve these in a timely manner. Builds strong relationships based on trust with employees and leaders throughout their customer teams . Partners with Business Leaders in developing team plans to support the business strategy. Coaches and empowers leaders during the entire employee life cycle, regarding HR matters/challenges and facilitates effective and proactive decision-making to ensure solutions are realistic, fair, timely, consistent, transparent and effective. Provides input in design and development of company-wide HR initiatives and programs to ensure alignment with business requirements. Leads HR Functional Projects . Manages and resolves complex employee relations matters. Conducts effective, thorough and objective investigations where required. Assists in developing, implementing and administrating HR policies/procedures, ensuring compliance with relevant statutory legislation and industry best practice. Involvement in departmental projects as required/based on experience/expertise . Works closely and flexibly with other HR team members locally and across the Cook organisation. Collects and analyses employment data for recommendations to the management team, maintaining records as needed and providing HR Leadership with new HR strategy proposals. Manages the entire recruitment and selection process in line with business needs, continually looking to introduce improvements where possible. Trains hiring managers in interviewing, employee selection skill and other employment law matters. Provides thorough, regular status updates to hiring managers on recruitment, turnover, headcount and employee issues. Participates in the development and delivery of company induction process for new starters. Benchmarks compensation / benefit packages and assists with compensation queries as necessary. All other duties as assigned. Ensure that Cook's Code of Conduct is considered in all business matters carried out on Cook's behalf. Qualifications Relevant third level qualification and/or other relevant certification. Five years Generalist/Specialist experience preferred, ideally gained in a similar environment based in a relevant country. Fluency in another major European language other than English strongly preferred. Excellent written and spoken English. Proven exposure to the full suite of HR activities, including recruitment, employee relations, compensation & benefits and performance management. Willingness and experience in delivering training. Excellent problem solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision . Proven organisational skills. Excellent interpersonal and communication skills. Ability to maintain confidentiality at all times. Strong knowledge of computer software. Willingness and availability to travel on company business. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
Overview The primary responsibility of this position is to support / lead on the design, development and taking to market of medical devices for Cook Medical. Position: Research & Development Engineer 2 Reporting to: Team Lead, Research and Development / Manager, Research and Development Responsibilities Perform Duties of Research & Development Engineer 2: Design development, prototyping, test method design, design evaluation, design reviews, design specifications, design verification and validation, design protocols and reports, transfer to production activities in a timely effective manner. Product testing and evaluation, completion of test reports to support design selection. Preparation and presentation of design reviews. Product risk analysis and risk management. Contribute towards process development during introduction /development of new equipment and production processes as required for any new manufacturing techniques. Source new materials components and equipment. Development of component specifications, inspection methods, bills of materials and manufacturing processes. Introduction of new equipment, materials and technologies. As required work closely with Key Opinion Leaders, physicians, product managers and team to develop innovative medical devices to improve patient care. Work closely with Project Lead and take responsibility for assigned research and development project tasks: Manage and drive assigned project tasks to ensure timely completion of project milestones. Work closely with cross functional groups to achieve project and company goals. Product performance evaluations. Contribute to innovation and creativity within team through filing of disclosures and patents. Hold regular project meetings and document minutes and actions. Ensure project milestones are achieved to meet business metrics. Communications: Regular communication to cross-functional teams and senior management. Project status communications and reporting. Remain on the forefront of emerging industry practices. Educating oneself in the medical area for which the new devices are being developed in order to have an appreciation for what needs to be achieved with these products. Support other cross functional groups to deliver company goals. Ensure that Cook's Code of Conduct is considered in all business matters carried out on Cook's behalf. Qualifications Bachelor's degree is required, preferably in engineering or a related field. Minimum of 3 years' relevant experience is desired. Project planning/execution skills. Execution of project in a timely effective manner. Knowledge of anatomy and physiology. Good mechanical design and understanding of engineering fundamentals with medical device materials knowledge. Statistical understanding and experience. Manufacturing design and process understanding. Good working knowledge of Solidworks and/or Pro Engineer CAD. Strong technical writer. Knowledge of relevant ISO, EU, FDA medical device standards regulations is required. Willingness and availability to travel on company business. About Cook Limerick Cook Medical has been in Limerick since 1996, starting out with labeling and distribution and steadily growing and evolving to include manufacturing, centralised customer support and on to collaborative product development in the Innovation Centre. The Ireland location is our European headquarters and houses our EMEA Support Centre. This location currently employs more than 1000 people and manufactures 10% of Cook's products for global markets. Research and Development in Limerick Our mission with R&D is to invent, manufacture, and deliver a unique portfolio of medical devices to the healthcare systems of the world. Our R&D team in Limerick is split into two divisions, Vascular and Medsurg. The R&D engineering teams are responsible for bringing a product from idea or concept all the way to market launch. The R&D Vascular division in Limerick has two programs, peripheral arterial disease (PAD) and venous therapies. The R&D engineers have the opportunity to create novel ideas within feasibility, learn and meet the requirements to bring a medical device through verification and validation, generation of a design history file and be a part of bringing a new product onto the market. All this is done through collaboration within small or large R&D teams and working with cross functional teams both locally in Limerick and globally with our sister companies. Our employee benefits include: Hybrid Work Model Company sponsored Defined Contribution pension scheme Medical Health Insurance cover for you and your immediate family Life Assurance and Income Protection cover Educational Assistance Performance related Bonus Extensive health & wellness program including Indian head massages, healthy lifestyle seminars, mindfulness courses, physio sessions, flu vaccinations, nutrition talks Fully equipped gym on site 39-hour week with flexible start & finish times Paid time off to participate in volunteer activities Free parking Subsidised restaurant Sports & Social club #LI-Hybrid #LI-RM1 To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
Overview The Director of Post Market Quality Assurance (PMQA) is responsible for ensuring the effectiveness and compliance of complaints, adverse event reports, recalls, and related post market processes within the global corporate quality management system. This role provides leadership and direction to global Quality Assurance teams by inspiring international teams, fostering a culture of collaboration, accountability, and high performance to ensure consistent delivery of centralized capabilities across all markets, leading to positive customer experiences. Responsibilities Direct and maintain a scalable, global structure for post market quality assurance ensuring clear communication and alignment with regional regulatory needs and business objectives. Develop and lead strategic vision and objectives for the global post market quality assurance team, ensuring alignment with overall corporate goals, regulatory requirements, and operational excellence initiatives. Collaborate closely with global functional leadership to ensure local market needs are integrated into global strategies. Provide leadership and mentorship and technical expertise to a diverse geographically dispersed post market quality assurance team, ensuring alignment with global standards and regional needs. Oversee and manage post market quality assurance budgets, including cost tracking, and strategic planning to support global operational priorities. Oversee and ensure that all post market quality activities comply with applicable regulations, including but not limited to: ISO13485, US FDA CFR Part 820, State Council Order No. 739- China, PMD Act, Law Act 145- Japan, Medical Device Management Act- Taiwan, Medical Devices Act- Korea, Good Distribution Practices-Thailand, etc. Proactively monitor regulatory changes and lead updates to post market quality assurance to maintain compliance. Drive adherence to relevant Quality Management Systems and Business Processes, promoting a culture of quality and organizational effectiveness. Engage effectively with stakeholders across all levels of the global organization, including regional regulatory agencies, to foster strategic relationships, influence policy, and ensure compliance. Lead cross-functional collaboration to optimize post market quality assurance processes. Foster a high-performance culture focused on talent development, succession planning, and continuous improvement. Establish and maintain global best practices, standardised policies, and/or procedural controls as needed to ensure consistency, accuracy and compliance of PMQA work outputs and systems. Balance standardization with regional flexibility where necessary. Champion a continuous improvement culture by leading initiatives that leverage AI and digital tools, automation, and innovate processes to enhance efficiency, accuracy and compliance in PMQA activities. Ensure local and corporate entities fulfil PMQA economic operator roles and responsibilities, including those for in-country representatives. Oversee the health of the PMQA QMS through proactive data collection, trend analysis, and implementation of improvement actions. Direct leadership to ensure compliance of the PMQA QMS with global QA policies, procedures, and direction. Oversee customer complaints, recall, and adverse reporting processes, ensuring appropriate handling, escalation, and resolution by relevant teams Serve as the Global Process Owner and represent Cook during internal and external audits. Represent PMQA globally, participating in working groups and supporting the voice of Cook and patients in industry guidance and regulation commentary Ensure post market quality assurance team members possess the requisite technical skills, experience, and training to perform their work. Provide strategic recommendations for workforce planning and contribute significantly to employee related decisions and development initiatives. Foster and maintain a positive, inclusive and productive work environment aligned with Cook's culture and values. Maintain overall accountability for PMQA QMS performance, communicating effectiveness and improvement needs to executive management and ensuring timely corrective actions. Willingness and availability to travel globally on company business. Qualifications Bachelor's degree or equivalent in Quality, Science or Engineering is required. A minimum of 12 years' experience in a regulated industry in a similar role preferred. Minimum of 8 years management experience leading Quality professionals. Working knowledge and experience applying medical device regulations and standards. ISO13485 and regional regulations for PMDA & TMG, MFDS, TFDA, US FDA, EUMDR, NMPA & SHMPA, and other health authorities desirable. Knowledge and experience of Quality Assurance, Quality Engineering and Regulatory Affairs, manufacturing and distribution operations. Knowledge of customer complaint management and recall management globally. Strong leadership and team management capabilities, with demonstrated success in guiding and developing global teams. Ability to lead and deliver multiple complex global projects simultaneously within deadlines. Ability to develop and maintain strong working relationships with internal and external stakeholders. Adapt to dynamic landscapes and organizational changes, with the ability to adjust quickly and effectively in a change-driven environment. Excellent problem-solving abilities and the capacity to work effectively both collaboratively and independently in environments with minimal supervision. Excellent organizational and planning abilities, complemented by keen attention to detail. Demonstrated ability to work in a fast-paced, high-pressure environment and meet deadlines. Collaborative team player with a proven ability to foster trust, open communication, and effective collaboration across diverse teams and stakeholders. Effective communication and interpersonal skills to build relationships across diverse geographies and cultures. Self-motivated and proactive, with a passion for driving quality and operational excellence. Flexibility to work across global time zones as required. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
