Verification & Compliance Specialist / Verification & Compliance Specialistess

Job Opportunity: Verification & Compliance Specialist

Proclinical is seeking a Verification & Compliance Specialist to join our regulatory team for a six-month contract. In this role, you will independently review and assess third-party medical devices and in vitro diagnostics for compliance with European (EU-MDR, EU-IVDR) and Swiss (MepV, IvDV) regulations. This position is ideal for a detail-oriented professional with strong regulatory expertise and excellent communication skills.

Key Responsibilities:

• Conduct regulatory reviews, including the assessment of technical documentation, declarations of conformity (DoC), CE certificates, and labeling of third-party medical devices and in vitro diagnostics.
• Ensure compliance with labeling obligations under Swiss CH-REP (Authorized Representative) and importers according to MepV and IVDV.
• Communicate with suppliers and partners to request, review, and clarify missing regulatory evidence and quality agreements.
• Provide recommendations for the approval or rejection of third-party products for the Swiss market.
• Support operational regulatory activities as needed, including supplier inquiries and document reviews.

Key Skills and Requirements:

• Degree in medical technology, natural sciences, industrial engineering, or a related field.
• Proven experience in regulatory affairs or quality management within the medical technology or in vitro diagnostics sector.
• Comprehensive knowledge of EU-MDR, EU-IVDR, Swiss MEPV, and IVDV regulations.
• Practical experience with third-party processes, including auditing, approval, or verification of supplier and third-party documents.
• Proficiency in German and English, both written and spoken.

If you are interested in this exciting opportunity, please apply online using the form below. Only applications matching the job profile will be considered.

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