Verification & Compliance Specialist
Core
Regulatory verification and assessment of third-party medical devices and IVD products against EU and Swiss regulations.
Role type
Senior Regulatory Affairs Specialist (Contractor)
Builds
Compliance documentation and product release recommendations for the Swiss market
Domain
Medtech / In-vitro Diagnostics (IVD) / Regulatory Affairs
Required skills
Regulatory Affairs expertise, Quality Management, EU-MDR/IVDR knowledge, Swiss MepV/IvDV knowledge, Third-party documentation audit, Vendor management, Technical writing
Preferred skills
None stated
Technologies
None stated
Responsibilities
Verify and evaluate technical documentation, Declaration of Conformity (DoC), CE certificates, and labeling of third-party products; Communicate with suppliers to request missing regulatory evidence; Provide recommendations for product release or blocking; Support operational regulatory tasks like supplier inquiries and document review
Seniority
Senior, hands-on IC
