Description

MDR/IVDR-  Verification and Compliance Specialist – 7075

Our client is a leading Swiss multinational healthcare company Rotkreuz, Switzerland. Operating in Pharmaceuticals and Diagnostics, it is one of the world’s largest biotech companies and a global leader in in-vitro diagnostics and cancer treatments. Our client is known for its strong focus on innovation, particularly in personalized healthcare, and has played a major role in developing treatments for oncology, immunology, infectious diseases, and neuroscience.

The ideal candidate is a qualified professional with a degree in medical technology, natural sciences, or industrial engineering. They will have at least three years of experience in regulatory affairs or quality management within the medtech/IVD industry. Sound knowledge of the EU-MDR/IVDR and the Swiss MepV/IvDV is essential, as is practical experience in verifying third-party documentation

This is a 6 months contract role to be working onsite in their Rotkreuz office.

Main Responsibilities

·      Regulatory Verification: Independent review and evaluation of technical documentation, Declarations of Conformity (DoC), CE certificates, and markings for third-party medical devices and in-vitro diagnostics; verification of correct labeling with regard to CH-REP (Swiss Authorized Representative) and importer obligations In accordance with MepV/IvDV.

·      Vendor & Partner Management: Communication with suppliers and partners to request, review, and clarify missing regulatory documentation and quality agreements.

·      PRRC Support: Preparation of recommendations for the approval or blocking of third-party products for the Swiss market.

·      Operational support in the area of ​​regulatory affairs as needed: e.g., supplier inquiries, document review (non-exhaustive list)

Qualifications and Experience:

·      Relevant Swiss working/residency permit or Swiss/EU-Citizenship required

·      Successfully completed degree in medical technology, natural sciences, industrial engineering, or a comparable qualification

·      Regulatory expertise: Demonstrable, several years (3+ years) of professional experience in regulatory affairs/quality management in the medtech or IVD sector

 Good Knowledge of:

 ·      EU MDR (2017/745) and EU IVDR (2017/746)

·      Swiss Medical Devices Ordinance (MepV) and In Vitro Diagnostics Ordinance (IvDV)

·      Experience with third-party processes: Practical experience in auditing, approving, or verifying supplier and third-party documentation

·      Fluent German and English, both written and spoken