MDR​/IVDR – Verification & Compliance Specialist (7075

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.

• 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)

• 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

• 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