• Maintain an excellent understanding of global medical device regulations in relation to Post Market Surveillance (PMS), Post Market Clinical Follow Up (PMCF), Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs).
• Responsibility for implementing regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, MDR 2017/745, FDA QSP 21CFR Part 820 and others as required.
• Input and adherence to the scheduling and management of PMS plans and reports, PMCF plans and reports and clinical evaluations. Maintains appropriate regulatory records to demonstrate compliance with applicable regulations.
• Liase and advise other Cook functional units (Engineering, Divisions, Quality etc) of the relevant requirements for PMS and PMCF and ensure the outputs from the individual functional units meet the applicable regulatory requirements. Review and analysis of data for same.
• Preparation of relevant information / responses for regulatory submissions, working with other members of the RA department.
• Review & analysis of adverse event / complaint information where required.
• Cover for Regulatory Reporting, this includes Adverse Event Reporting (MDR, Vigilance, etc), review of associated correspondence to applicable Regulatory bodies, Health Risk Assessments (HRA), Recall etc as required.
• Ensures, in conjunction with Medical Affairs and other personnel, that the clinical requirements of the product are adequately addressed.
• Conduct systematic, comprehensive searches of published medical literature; write clear and effective search protocols and reports.
• Provide interpretation and analysis of clinical and non-clinical data pertinent to Cook Ireland medical devices (e.g., literature reviews, abstracts, posters, presentations, manuscripts, Clinical Evaluation Reports, and clinical study reports).
• Participate, as required, in development projects and prepare project deliverables, including literature search and examination of clinical evidence. Provide input to risk assessment and product labeling as well as clinical / regulatory strategies.
• Preparation / input into Clinical Evaluation Plans and Clinical Evaluation Reports.
• Communicates directly with Notified Bodies, Competent Authorities and other Regulatory Authorities as required.
• Act as the Regulatory representative for participation in internal and external regulatory audits.
• Coordinate multiple projects at one time and provide regular reports to Management and other stakeholders as required.
• Perform additional duties as assigned
• Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.

• Third level Qualification in any of the following areas: Science/Engineering, Pharmacy, Nursing desired.
• 2 years’ experience in a regulated industry in a similar role would be advantageous.
• Knowledge of regulations pertaining to PMS, PMCF and CERs particularly in relation to the EU (MDD & MDR regulations) would be advantageous.
• Knowledge of medical device quality standards/practises or similar regulated industry knowledge.
• Good communication and inter-personal skills with ability to communicate clearly and concisely in both spoken and written form.
• Participate in a team-based environment.
• Proven problem-solving skills.
• Good technical writing skills; advantageous to have experience in medical writing.
• Knowledge / use of search databases for published literature (Embase, MEDLINE etc.)
• Good computer skills including knowledge of Microsoft®
• Proven organisational skills.
• High level of self-motivation.
• Willingness and availability to travel on company business as required.

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 one of the world’s largest private companies, 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 being a good corporate citizen is the right thing to do.

Cook Medical has been in Limerick since 1993. Since opening, we have become a European headquarters for many of Cook’s business functions.

With a global workforce of 12,000, we employ over 850 people in Ireland who bring Endoscopy, Urology and Peripheral Intervention products from conception to commercialisation.

Our employee benefits include:

• Hybrid working - mix of remote & onsite
• 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