MDR/IVDR – Verification & Compliance Specialist (7075)

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

MDR/IVDR- Verification and Compliance Specialist – 7075

Our client is a leading Swiss multinational healthcare company Rotkreuz, 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 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 EU-MDR/IVDR and the Swiss MepV/IvDV is essential, as is practical experience in verifying third‑party documentation

This is a 6 months contract role to be working onsite in their Rotkreuz office.

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

• EU MDR (2017/745) and EU IVDR (2017/746)
• 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