Verification & Compliance Specialist (m/w/d)

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

For one of our clients, a global pioneer in medical diagnostics, we are currently looking for an experienced Verification & Compliance Specialist to strengthen their Regulatory Team.

In this role, you will independently handle the regulatory verification and assessment of third-party products with regard to applicable European (EU-MDR/ EU-IVDR) and Swiss (MepV / IvDV) regulations.

General Information:

• Duration: 6 months
• Extension: not foreseen
• Contract type: temporary contract via Randstad (employment)
• Home Office: not possible
• Working hours: standard

Tasks & Responsibilities:

• Regulatory verification: Independent review and assessment of technical documentation, Declarations of Conformity (DoC), CE certificates, and labeling for third-party medical devices and in vitro diagnostics; verification of correct labeling regarding 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 evidence and quality agreements.
• PRRC support: Preparation of recommendations regarding the release or blocking of third-party products for the Swiss market. Operational support in the regulatory area on an as-needed basis: e.g., supplier inquiries, document review (non-exhaustive list)

Must Haves:

• Successfully completed degree in medical technology, natural sciences, industrial engineering, or a comparable qualification
• Regulatory expertise: Proven professional experience (3+ years) in Regulatory Affairs / Quality Management within the MedTech or IVD sector
• In-depth knowledge of Swiss In Vitro Diagnostic Medical Devices Ordinance (IvDV) and Swiss Medical Devices Ordinance (MepV)
• Experience with third-party processes: Practical experience in auditing, approving, or verifying documentation from suppliers and third-party providers
• Business-fluent German and English (written and spoken)