Regulatory Scientist 2

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).

NPI: The Regulatory Scientist 2 helps develop regulatory strategies, performs activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets. The Regulatory Scientist 2 serves as a communication liaison between the Cook manufacturer and the Cook local affiliates or regulatory authorities.

Reporting to: Clinical & Post Market Surveillance: Senior Manager Post Market Surveillance, Regulatory Affairs or

NPI: Principal Regulatory Scientist

Find out more about Cook Medical here

• Clinical & 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.
• NPI
• Maintain an excellent understanding of global medical device regulations for specific jurisdictions as assigned such as regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745 and FDA QSP 21CFR Part 820 as required.
• Ensures a thorough understanding of the products they are assigned.
• Communicates country/region specific regulatory requirements to the regulatory specialists/ managers.
• Develop global regulatory strategies for Cook medical devices in collaboration with other regulatory affairs or clinical personal (as applicable).
• Advise other Cook functional units (engineering, marketing, operations, quality etc) of the requirements in each target market.
• Ensure the outputs from the individual functional units meet the applicable regulatory requirements.
• Plans and prepares regulatory submissions for specific target markets for new products and product changes as required.
• Communication of the clinical requirements for regulatory registrations for the product and working as part of a cross functional team to ensure that they are adequately addressed.
• Communicates directly with notified bodies and other regulatory authorities to ensure product approvals are achieved in a timely manner.
• 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.
• Provides support to currently marketed products as necessary including input on change requests, etc.
• Maintains and organises appropriate regulatory records to demonstrate compliance with applicable regulations.
• Provides regulatory support to Cook functional units such as the SSC, tenders, customer quality and distribution.
• Performs additional duties as assigned.
• Can act as a designee for the Regulatory Affairs Specialist or Regulatory Affairs Senior Scientist if required.
• 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). (Clinical & Post Market Surveillance Role)
• Ideally have knowledge of requirements in MDSAP countries including regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745 and FDA QSP 21CFR Part 820 as required. (NPI Role) 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 ^® Office.
• Proven organisational skills.
• High level of self-motivation.
• Willingness and availability to travel on company business as required.