Verification & Compliance Specialist

Verification & Compliance Specialist # (m/f/d) freelance/in temporary permanent employment for a project Zug Start date: immediately Reference number: 890956/1 Tasks ### • Regulatory verification: Independent examination and evaluation of Technical Documentation, Declarations of Conformity (DoC), CE certificates, and labeling of 3rd-party medical devices and in-vitro diagnostics • Verification of correct labeling regarding CH-REP (Swiss Authorized Representative) and importer obligations according to MepV and IvDV • Vendor & Partner Management: Communication with suppliers and partners to request, review, and clarify missing regulatory evidence and quality agreements • PRRC support: Creation of recommendations for the release or blocking of third-party products for the Swiss market • Operational support in the Regulatory area as needed: e.g., supplier inquiries, document review (non-exhaustive list) Profile ### • Successfully completed studies in the field of medical technology, natural sciences, industrial engineering, or a comparable qualification • Regulatory expertise with demonstrable, solid professional experience in Regulatory Affairs / Quality Management in the medtech or IVD sector • Sound knowledge of EU-MDR (2017/745) and EU-IVDR (2017/746) • Sound knowledge of the Swiss Medical Devices Ordinance (MepV) and In-vitro Diagnostics Ordinance (IvDV) • Practical experience with 3rd-party processes • Experience in auditing, releasing, or verifying supplier and third-party documentation • Business fluent German and English skills in speaking and writing Benefits ### • Dynamic and innovative market environment • Dedicated, innovative and friendly team