Regulatory Compliance Specialist (m/w/d)
Core
Verify and evaluate third-party medical devices and IVD products for compliance with EU (MDR/IVDR) and Swiss regulations.
Role type
Regulatory Compliance Specialist
Builds
Regulatory verification of third-party products for Roche Diagnostics
Domain
Medical technology / In-vitro diagnostics / Regulatory Affairs
Deliverable
client delivery
Required skills
EU-MDR, EU-IVDR, Swiss MepV, Swiss IvDV, third-party documentation audit, vendor management
Preferred skills
null
Technologies
null
Responsibilities
Independently verify and evaluate technical documentation, declarations of conformity, CE certificates, and labeling of third-party medical devices and IVDs; Communicate with suppliers and partners to request missing regulatory evidence and quality agreements; Provide recommendations for releasing or blocking third-party products for the Swiss market; Support operational regulatory tasks such as handling supplier inquiries and document review.
Seniority
Mid-level, hands-on IC
