MDR/IVDR Verification & Compliance Specialist – Onsite

CTC Resourcing Solutions; Basel; Vor Ort; CHF 100.000 - 145.000; Vollzeit

Zusammenfassung

CTC Resourcing Solutions is seeking a MDR/IVDR Verification and Compliance Specialist for a 6‑month onsite contract in Rotkreuz, Switzerland. The candidate should have a degree in medical technology, natural sciences, or industrial engineering and 3+ years in regulatory affairs/quality management within the medtech/IVD sector.

Fluency in German and English is required. Key duties include regulatory verification of technical documentation, DOc/CE certificates, and CH-REP obligations, plus vendor

Qualifikationen

• Degree in medical technology, natural sciences, or industrial engineering.
• Regulatory expertise: several years (3+ years) in regulatory affairs/quality management in medtech/IVD.
• Experience with EU MDR/IVDR and Swiss MepV/IvDV is essential.

Aufgaben

• Regulatory verification: review DoC, CE certificates, and labeling for CH-REP and importer obligations.
• Vendor & Partner Management: request, review, and clarify missing regulatory documentation and quality agreements.
• PRRC Support: provide recommendations for approval or blocking of third‑party products for Swiss market.
• Operational support in regulatory affairs, such as supplier inquiries and document review.

Kenntnisse

Regulatory affairs

Quality management

Vendor management

PRRC support

Documentation review

Ausbildung

Medical technology degree

Natural sciences degree

Industrial engineering degree

Jobbeschreibung

CTC Resourcing Solutions is seeking a MDR/IVDR Verification and Compliance Specialist for a 6‑month onsite contract in Rotkreuz, Switzerland. The candidate should have a degree in medical technology, natural sciences, or industrial engineering and 3+ years in regulatory affairs/quality management within the medtech/IVD sector.

Fluency in German and English is required. Key duties include regulatory verification of technical documentation, DOc/CE certificates, and CH-REP obligations, plus vendor