German-speaking Regulatory Affairs – MedTech/IVD, 6m

CTC Resourcing Solutions; Risch-Rotkreuz; Vor Ort; CHF 90.000 - 110.000; Vollzeit

Zusammenfassung

CTC Resourcing Solutions is seeking a German-speaking Regulatory Affairs Consultant for a 6-month contract in Rotkreuz, Switzerland. You will verify technical documents, ensure CH-REP labeling compliance, and support PRRC activities for Swiss MepV/IvDV requirements.

You bring a degree in medical technology, natural sciences, or industrial engineering and 3+ years in medtech/IVD regulatory affairs or quality management, with fluent German and English.

Qualifikationen

• Degree in medical technology, natural sciences, or industrial engineering.
• 3+ years of regulatory affairs or quality management in medtech/IVD.
• Knowledge of MepV and IvDV; experience verifying third-party docs.
• German and English fluent in writing and speaking.

Aufgaben

• Regulatory verification of DoCs, CE certificates, labeling per MepV/IvDV.
• Vendor and partner management for regulatory documentation and quality agreements.
• PRRC support: advise on approval or blocking of third-party products for Swiss market.
• Operational regulatory affairs support as needed (doc review, supplier inquiries).

Kenntnisse

Regulatory affairs

Quality management

German language

English language

Ausbildung

Degree in medical technology / natural sciences / industrial engineering

Jobbeschreibung

CTC Resourcing Solutions is seeking a German-speaking Regulatory Affairs Consultant for a 6-month contract in Rotkreuz, Switzerland. You will verify technical documents, ensure CH-REP labeling compliance, and support PRRC activities for Swiss MepV/IvDV requirements.

You bring a degree in medical technology, natural sciences, or industrial engineering and 3+ years in medtech/IVD regulatory affairs or quality management, with fluent German and English.