Regulatory Affairs Consultant / Regulatory Affairs Consultantess

Regulatory Affairs Consultant – Swiss MepV/IvDV – 7107 URA

Our client is a leading Swiss multinational healthcare company headquartered in Basel, Switzerland. Operating in the Pharmaceuticals and Diagnostics sectors, it stands as one of the largest biotech companies globally and a pioneer in in-vitro diagnostics and cancer treatments. Known for its strong focus on innovation, our client has been instrumental in developing groundbreaking treatments in oncology, immunology, infectious diseases, and neuroscience.

Position Overview

We are seeking an ideal candidate who is a qualified German-speaking professional with a degree in medical technology, natural sciences, or industrial engineering. The successful applicant should possess a minimum of three years of experience in regulatory affairs or quality management within the medtech or IVD industry. A solid understanding of the Swiss In Vitro Diagnostics Ordinance (IvDV) and the Swiss Medical Devices Ordinance (MepV), along with practical experience in verifying third-party documentation, is essential. This is a six-month contract role based in our client's office in Rotkreuz, Switzerland.

Main Responsibilities

• Regulatory Verification: Conduct independent reviews and evaluations of technical documentation, Declarations of Conformity (DoC), CE certificates, and markings for third-party medical devices and in-vitro diagnostics. Ensure correct labeling in accordance with CH-REP (Swiss Authorized Representative) and importer obligations as stipulated by MepV/IvDV.
• Vendor & Partner Management: Communicate with suppliers and partners to request, review, and clarify any missing regulatory documentation and quality agreements.
• PRRC Support: Prepare recommendations for the approval or rejection of third-party products for the Swiss market.
• Operational Support: Provide assistance in regulatory affairs as necessary, including supplier inquiries and document reviews (this list is non-exhaustive).

Qualifications and Experience

• Relevant Swiss working or residency permit or Swiss/EU citizenship is required.
• Successfully completed degree in medical technology, natural sciences, industrial engineering, or a comparable qualification.
• Regulatory Expertise: A minimum of three years of demonstrated professional experience in regulatory affairs or quality management within the medtech or IVD sector.
• Good Knowledge of:
  • Swiss Medical Devices Ordinance (MepV) and In Vitro Diagnostics Ordinance (IvDV).
  • Experience with third-party processes, including practical experience in auditing, approving, or verifying supplier and third-party documentation.
• Fluent in both German and English, with strong written and spoken communication skills.

Apply online using the form below. Only applications matching the job profile will be considered.