Regulatory Affairs Consultant – Swiss MepV/IvDV (7107)

Regulatory Affairs Consultant – Swiss MepV/IvDV

Join a leading Swiss multinational healthcare company headquartered in Basel, operating as a global leader in in-vitro diagnostics and cancer treatments. With a strong focus on innovation in personalized healthcare, the organization plays a major role in developing treatments for oncology, immunology, infectious diseases, and neuroscience. This six-month contract role is based in the office in Rotkreuz, Switzerland.

Main Responsibilities

• Conduct independent review and evaluation of technical documentation, Declarations of Conformity (DoC), CE certificates, and markings for third-party medical devices and in-vitro diagnostics.
• Verify correct labeling with regard to CH-REP (Swiss Authorized Representative) and importer obligations in accordance with MepV/IvDV.
• Communicate with suppliers and partners to request, review, and clarify missing regulatory documentation and quality agreements.
• Prepare recommendations for the approval or blocking of third-party products for the Swiss market.
• Provide operational support in the area of regulatory affairs as needed, including supplier inquiries and document review.

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.
• Demonstrable three or more years of professional experience in regulatory affairs or quality management in the medtech or IVD sector.
• Good knowledge of the Swiss Medical Devices Ordinance (MepV) and In Vitro Diagnostics Ordinance (IvDV).
• Practical experience in auditing, approving, or verifying supplier and third-party documentation.
• Fluent German and English, both written and spoken.