Verification and Compliance Engineer

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

Responsibilities:

• Regulatory verification: Independent review and evaluation of technical documentation, declarations of conformity (DoC), CE certificates and markings of 3rd party medical devices and in vitro diagnostics, verification of the correct labeling with regard to CH-REP (Swiss Authorized Representative) and importer obligations according to MedDO/IvDO.

• Vendor & Partner Management: Communication with suppliers and partners to demand, review and clarify missing regulatory evidence and quality agreements.

• PRRC Support: Creation of recommendations for the release or blocking of third-party products for the Swiss market.

• Operational support in the area of regulatory as required: e.g. supplier enquiries, document review (non-exhaustive list)

Must Haves:

• 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: Demonstrable, several years (3+ years) of professional experience in Regulatory Affairs / Quality Management in the medtech or IVD sector

• In-depth knowledge

  • • Focus: Swiss In-vitro Diagnostics Ordinance (IvDV)
    • Swiss Medical Devices Ordinance (MedDO)

• Experience with 3rd party processes: Hands-on experience in auditing, approving or verifying supplier and third-party documentation