MDR/IVDR - Verification & Compliance Specialist / MDR/IVDR - Verification & Compliance Specialistess

MDR/IVDR- Verification and Compliance Specialist – 7075

Join a prestigious Swiss multinational healthcare company based in Rotkreuz, Switzerland. Our client operates within the Pharmaceuticals and Diagnostics sectors, making it one of the world’s largest biotech firms and a global frontrunner in in-vitro diagnostics and cancer treatments. Renowned for its dedication to innovation, particularly in personalized healthcare, the company plays a pivotal role in advancing therapies in oncology, immunology, infectious diseases, and neuroscience.

Role Overview

The ideal candidate will be a qualified professional with a degree in medical technology, natural sciences, or industrial engineering. A minimum of three years of experience in regulatory affairs or quality management within the medtech/IVD industry is essential. Candidates should possess a solid understanding of EU-MDR/IVDR and the Swiss MepV/IvDV regulations, along with practical experience in verifying third-party documentation.

This position is a 6-month contract requiring onsite work at the Rotkreuz office.

Main Responsibilities

• Regulatory Verification: Conduct independent reviews and evaluations of technical documentation, Declarations of Conformity (DoC), CE certificates, and markings for third-party medical devices and in-vitro diagnostics. Ensure correct labeling in accordance with Swiss Authorized Representative (CH-REP) and importer obligations as per MepV/IvDV.
• Vendor & Partner Management: Liaise with suppliers and partners to request, review, and clarify any missing regulatory documentation and quality agreements.
• PRRC Support: Prepare recommendations regarding the approval or rejection of third-party products for the Swiss market.
• Operational Support: Provide assistance in the regulatory affairs area as needed, including supplier inquiries and document reviews.

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.
• Proven regulatory expertise with a minimum of three years of professional experience in regulatory affairs or quality management in the medtech or IVD sectors.
• 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, including auditing, approving, or verifying supplier and third-party documentation.
• Fluent in both German and English, written and spoken.

Apply online using the form below. Only applications matching the job profile will be considered.