Regulatory Affairs Consultant – Swiss MepV/IvDV (7107)

Regulatory Affairs Consultant – Swiss MepV/IvDV – 7107 URA

Our client is a leading Swiss multinational healthcare company headquartered in Basel, 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 German speaking 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 Swiss In Vitro Diagnostics Ordinance (IvDV) Swiss Medical Devices Ordinance (MepV) and practical experience in verifying third-party documentation. This is a 6 months contract role to be working from their office in Rotkreuz in Switzerland.

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:
• 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

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