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...

• 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...