For our client based in Rotkreuz (Switzerland), we are looking for a Verification & Compliance Specialist to be responsible for the regulatory verification and assessment of third-party products in relation to the applicable European (EU-MDR / EU-IVDR) and Swiss regulations (MepV / IvDV).
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 correct labeling with regard to CH-REP (Swiss Authorised Representative) and importer obligations according to MepV/IvDV.
- Vendor & Partner Management: Communication with suppliers and partners to request, review and clarify missing regulatory documentation and quality agreements.
- PRRC support: Creating recommendations for the approval or blocking of third-party products for the Swiss market.
- Operational support in the area of regulatory affairs as needed: e.g. supplier inquiries, document review (non-exhaustive list)
Must-haves:
- Successfully completed studies in the field of medical technology, natural sciences, industrial engineering or a comparable qualification
- Regulatory Expertise: Proven, multi-year (3+years) professional experience in Regulatory Affairs / Quality Management in the Medtech or IVD sector
- Solid knowledge: Swiss In-vitro Diagnostic Regulation (IvDV) & Swiss Medical Devices Ordinance (MepV)
- Experience with 3rd-party processes: Practical experience in auditing, approving, or verifying supplier and third-party documentation
- Fluent in German and English, both spoken and written.
Contract Type: 6 months
Start Date: ASAP, latest 1st of November 2026
**While we appreciate every application, please note that due to the high volume of responses, we may only be able to contact shortlisted candidates.
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Regulatory Verification and Compliance Specialist Arbeitgeber: Actalent
Actalent ist ein hervorragender Arbeitgeber, der seinen Mitarbeitern in Burnsville, Minnesota, eine dynamische und kollaborative Arbeitsumgebung bietet. Mit einem starken Fokus auf technische Exzellenz und kontinuierliche Verbesserung ermöglicht das Unternehmen seinen Mitarbeitern, an innovativen Projekten im Bereich der Luft- und Raumfahrttechnik zu arbeiten und sich beruflich weiterzuentwickeln. Die angebotenen Vorteile, einschließlich flexibler Arbeitszeiten, umfassender Gesundheitsleistungen und einer 401(k)-Rentenplanung, tragen dazu bei, dass Mitarbeiter sich geschätzt und unterstützt fühlen.
