Regulatory Affairs Consultant – Swiss MepV/IvDV (German)

CTC Resourcing Solutions AG; Basel; Vor Ort; CHF 90.000 - 120.000; Vollzeit

Zusammenfassung

CTC Resourcing Solutions AG is seeking a Regulatory Affairs Consultant for a 6-month contract in Rotkreuz, Switzerland. Fluent German speakers with a degree in medical technology, natural sciences, or industrial engineering and at least 3 years in regulatory affairs or quality management in the medtech/IVD sector are preferred.

The role involves regulatory verification of documentation, DoCs, CE certificates, and CH-REP labeling; vendor/partner management; PRRC support for Swiss market

Qualifikationen

• Swiss working/residency permit or Swiss/EU-Citizenship required.
• Degree in medical technology, natural sciences, or industrial engineering.
• 3+ years of regulatory affairs/quality management in medtech/IVD.
• Knowledge of MepV and IvDV.
• Fluent German and English, both written and spoken.

Aufgaben

• Regulatory verification of technical documentation, DoC, CE certificates, and CH-REP labeling per MepV/IvDV.
• Vendor & partner management to request, review, and clarify missing regulatory documentation and quality agreements.
• PRRC support: recommendations for approval or blocking of third-party products for the Swiss market.
• Operational support in regulatory affairs (e.g., supplier inquiries, document reviews).

Kenntnisse

Regulatory affairs

Quality management

German language

English language

Ausbildung

Medical technology degree

Natural sciences degree

Industrial engineering degree

Jobbeschreibung

CTC Resourcing Solutions AG is seeking a Regulatory Affairs Consultant for a 6-month contract in Rotkreuz, Switzerland. Fluent German speakers with a degree in medical technology, natural sciences, or industrial engineering and at least 3 years in regulatory affairs or quality management in the medtech/IVD sector are preferred.

The role involves regulatory verification of documentation, DoCs, CE certificates, and CH-REP labeling; vendor/partner management; PRRC support for Swiss market