Regulatory Verification Specialist — MedTech (EU/Swiss MDR)

more-jobs; Zug; Vor Ort; CHF 110.000 - 140.000; Vollzeit

Zusammenfassung

more-jobs is seeking an experienced Verification & Compliance Specialist to join the Regulatory Affairs team on a 6-month onsite contract in Rotkreuz, Switzerland. The role focuses on EU MDR/IVDR and Swiss MepV/IvDV compliance for medical devices and IVDs.

You will review third-party documentation, support PRRC activities, and coordinate with suppliers. Fluent German and English are required, with at least three years in Regulatory Affairs or Quality within MedTech/IVD.

Qualifikationen

• 3+ years in Regulatory Affairs or Quality Management in MedTech/IVD.
• Strong knowledge of EU MDR/IVDR and Swiss MepV/IvDV.
• Experience with third‑party documentation review and verification.

Aufgaben

• Regulatory Verification: review DoC, CE certificates, and labeling for Swiss/European requirements.
• Vendor & Partner Management: request, review, and clarify missing regulatory documents.
• PRRC Support: advise on approval or restrictions for third‑party products.
• Operational Regulatory Support: assist with day‑to‑day regulatory tasks as needed.

Kenntnisse

Regulatory expertise

Documentation review

Supplier management

PRRC support

Analytical thinking

German language

Ausbildung

Degree in Medical Engineering, Life Sciences, Industrial Engineering

Jobbeschreibung

more-jobs is seeking an experienced Verification & Compliance Specialist to join the Regulatory Affairs team on a 6-month onsite contract in Rotkreuz, Switzerland. The role focuses on EU MDR/IVDR and Swiss MepV/IvDV compliance for medical devices and IVDs.

You will review third-party documentation, support PRRC activities, and coordinate with suppliers. Fluent German and English are required, with at least three years in Regulatory Affairs or Quality within MedTech/IVD.