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:
- Start date: ASAP
- Lastest start date: 01.11.2026
- Duration: 6 months
- Extension: not foreseen
- Contract type: temporary contract via Randstad (employment)
- Work location: Rotkreuz (ZG)
- Workload: 80-100%
- 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)
Sounds interesting? Apply now – we’re looking forward to receiving your applications!