Regulatory Scientist

Clinical & Post Market Surveillance:

The Regulatory Scientist 2 will be involved in the development and generation of post market surveillance (PMS) plans and reports for Cook Ireland medical devices. In addition, the Regulatory Affairs Specialist will perform activities associated with PMS, including Post Market Clinical Follow-Up (PMCF), and Clinical Evaluation Plans and Reports (CEPs, CERs).

Reporting to: Clinical & Post Market Surveillance: Senior Manager Post Market Surveillance

• 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 EU MDR 2017/745, ISO13485, MDD 93/42/EEC, FDA QSP 21CFR Part 820 and others as required.
• Create and conduct systematic literature searches using search databases for published literature (Embase, PubMed etc.). Write clear and effective search protocols and reports.
• Appraise clinical data relating to State of the Art (SOTA) and non-clinical and clinical data relating to Cook Ireland medical devices.
• Author Clinical Evaluation Protocols (CEPs) and Clinical Evaluation Reports (CERs) in accordance with internal procedures, ensuring the relevant regulatory requirements are addressed.
• 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.
• Liaise 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.
• Ensures, in conjunction with Medical Affairs and other personnel, that the clinical requirements of the product are adequately addressed.
• 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 labelling as well as clinical / regulatory strategies.

• 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, or Clinical, such as Pharmacy or Nursing, desired.
• 2 years’ experience in a regulated industry in a similar role would be advantageous.
• Knowledge of regulations pertaining to Post-market Surveillance and Clinical Evaluation would be advantageous. Particularly in relation to the EU (MDD 93/42/EEC, EU MDR 2017/745).
• 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 medical writing experience.
• Knowledge / use of search databases for published literature (Embase, PubMed 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.