Regulatory Affairs Consultant - Swiss MepV/IvDV - 7107 URA
Our client is a leading Swiss multinational healthcare company headquartered in Basel, Switzerland. Operating in Pharmaceuticals and Diagnostics, it is one of the world's largest biotech companies and a global leader in in-vitro diagnostics and cancer treatments. Our client is known for its strong focus on innovation, particularly in personalized healthcare, and has played a major role in developing treatments for oncology, immunology, infectious diseases, and neuroscience.
The ideal candidate is a qualified German speaking professional with a degree in medical technology, natural sciences, or industrial engineering. They will have at least three years of experience in regulatory affairs or quality management within the medtech/IVD industry. Sound knowledge of the Swiss In Vitro Diagnostics Ordinance (IvDV) Swiss Medical Devices Ordinance (MepV) and practical experience in verifying third-party documentation. This is a 6 months contract role to be working from their office in Rotkreuz in Switzerland.
Main Responsibilities
- Regulatory Verification: Independent review and evaluation of technical documentation, Declarations of Conformity (DoC), CE certificates, and markings for third-party medical devices and in-vitro diagnostics; verification of correct labeling with regard to 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 documentation and quality agreements.
- PRRC Support: Preparation of 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)
Qualifications and Experience:
- Relevant Swiss working/residency permit or Swiss/EU-Citizenship required
- Successfully completed degree in medical technology, natural sciences, industrial engineering, or a comparable qualification
- Regulatory expertise: Demonstrable, several years (3+ years) of professional experience in regulatory affairs/quality management in the medtech or IVD sector
- Good Knowledge of:
- Swiss Medical Devices Ordinance (MepV) and In Vitro Diagnostics Ordinance (IvDV)
- Experience with third-party processes: Practical experience in auditing, approving, or verifying supplier and third-party documentation
- Fluent German and English, both written and spoken
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Regulatory Affairs Consultant – Swiss MepV/IvDV – 7107 URA Arbeitgeber: CTC Resourcing Solutions
CTC Resourcing Solutions bietet eine herausragende Arbeitsumgebung für Fachkräfte im Bereich Biotechnologie und Pharma. Mit einem starken Fokus auf Teamarbeit und interdisziplinäre Zusammenarbeit in Visp, Schweiz, fördern wir eine Kultur der kontinuierlichen Verbesserung und beruflichen Weiterentwicklung. Unsere Mitarbeiter profitieren von flexiblen Arbeitszeiten, umfassenden Schulungsprogrammen und der Möglichkeit, an innovativen Projekten in einer dynamischen Branche teilzunehmen.
