Regulatory & Compliance Engineer — MedTech/IVD

Coopers Group; Risch-Rotkreuz; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Zusammenfassung

Coopers Group in Switzerland seeks a Regulatory Affairs professional to verify DoCs, CE certificates and labeling for Swiss market devices in the medtech/IVD sector.

You will manage vendors and partners, support regulatory decisions on releases or blocks, and provide operational regulatory assistance including supplier inquiries and document reviews. The role requires 3+ years of experience and fluent German and English, with IvDV and MedDO knowledge.

Qualifikationen

• Successfully completed studies in the field of medical technology, natural sciences, industrial engineering or a comparable qualification.
• Fluent in German and English, both written and spoken.
• Regulatory expertise: 3+ years in Regulatory Affairs / Quality Management in medtech or IVD.
• In-depth knowledge: IvDV, MedDO.

Aufgaben

• Regulatory verification of DoC, CE certificates and labeling for 3rd party medical devices and IVDs for Swiss entry.
• Vendor & Partner Management: communicate with suppliers to obtain and clarify missing regulatory evidence and quality agreements.
• PRRC Support: provide recommendations for release or blocking of third-party products for the Swiss market.
• Operational support: supplier inquiries and document reviews as needed.

Kenntnisse

German language

English language

Regulatory expertise

Auditing

Ausbildung

Medical technology / natural sciences / industrial engineering degree

Jobbeschreibung

Coopers Group in Switzerland seeks a Regulatory Affairs professional to verify DoCs, CE certificates and labeling for Swiss market devices in the medtech/IVD sector.

You will manage vendors and partners, support regulatory decisions on releases or blocks, and provide operational regulatory assistance including supplier inquiries and document reviews. The role requires 3+ years of experience and fluent German and English, with IvDV and MedDO knowledge.