MedTech Regulatory Verifier (IvDV/MepV)

Randstad Switzerland; Risch-Rotkreuz; Vor Ort; CHF 90.000 - 120.000; Vollzeit

Zusammenfassung

Randstad Switzerland is seeking an experienced Verification & Compliance Specialist to support the regulatory team for a client in the medical diagnostics sector. You will independently verify regulatory documentation for third-party medical devices and in vitro diagnostics, ensuring compliance with CH-REP and importer obligations under MepV/IvDV.

Required are a 3+ year track record in Regulatory Affairs/Quality Management within MedTech/IVD, deep IvDV/MepV knowledge, and fluent German and

Qualifikationen

• 3+ years in Regulatory Affairs / Quality Management in MedTech/IVD
• In-depth knowledge of IvDV and MepV (Swiss regulations)
• Experience auditing or reviewing supplier/third-party documentation
• Business-fluent German and English (written and spoken)

Aufgaben

• Regulatory verification: review DoC, CE certificates, labeling; CH-REP and importer obligations under MepV/IvDV
• Vendor & partner management: request and clarify missing regulatory information
• PRRC support: provide recommendations on release/blocking of third-party products for Swiss market

Kenntnisse

Regulatory verification

DoC review

Labeling compliance

Third-party QA liaison

Ausbildung

Medical technology / natural sciences degree

Comparable qualification in engineering/tech

Jobbeschreibung

Randstad Switzerland is seeking an experienced Verification & Compliance Specialist to support the regulatory team for a client in the medical diagnostics sector. You will independently verify regulatory documentation for third-party medical devices and in vitro diagnostics, ensuring compliance with CH-REP and importer obligations under MepV/IvDV.

Required are a 3+ year track record in Regulatory Affairs/Quality Management within MedTech/IVD, deep IvDV/MepV knowledge, and fluent German and