PRRC (Person Responsible for Regulatory Compliance)

About the Role:

We are seeking a qualified PRRC to join our team and oversee technical documentation for CE marking under the Medical Device Regulation (MDR). This role will involve managing and maintaining the regulatory documentation for multiple Class IIa and IIb medical devices, ensuring ongoing compliance with EU MDR requirements.

Key Responsibilities:

• Oversee the creation and updates of essential regulatory documents including CEP, CER, and PMCF Reports.

• Conduct literature reviews and perform benefit/risk calculations for Clinical Evaluation Reports (CER).

• Manage Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) activities, including the development and maintenance of Plans and Reports.

• Maintain and update the Risk Management file, Usability Engineering file, and Biological Safety Evaluation.

• Verify content of Instructions for Use (IFU) to ensure compliance with MDR requirements.

• Coordinate and manage regulatory updates and potential changes to SOPs.

• Serve as lead auditor for internal audits, including the preparation and execution of internal audit reports.

• Provide assistance with NB (Notified Body) auditors’ queries and non-conformities during external audits.

• Ensure timely completion of annual PSUR (Periodic Safety Update Report) and PMCFR (Post-Market Clinical Follow-up Report) for all certified devices.

Annual Work Cycle:

• JAN: Manage PSUR and PMCFR reports.

• JUN: Lead internal audit and update regulatory SOPs.

• AUG: Oversee internal audit review during management review meeting.

• DEC: Manage external audit and address queries and NCs from NB auditors.

Devices Managed:

• 2 x Class IIa (MDR) – Well-Established Technology (WET)

• 2 x Class IIb (MDR) – WET

• 1 x Class IIb (MDR) – New device

• Proven experience in regulatory affairs for medical devices, particularly under MDR.

• Strong knowledge of technical documentation requirements for CE marking, including clinical evaluation, risk management, and post-market surveillance.

• Experience with audit processes (internal and external) and responding to regulatory audits and non-conformities.

• Ability to review, update, and generate regulatory documents with attention to detail.

• Excellent communication skills and the ability to collaborate with cross-functional teams.

• Strong organizational skills and ability to meet deadlines in a structured work cycle.