Verification & Compliance Specialist

Verification & Compliance Specialist
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Roche Schweiz bridges the gap between pharmacy and diagnostics. Important research and development functions are located here. For our long-standing client, Roche Diagnostics International AG in Rotkreuz, we are looking for a

Verification & Compliance Specialist
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Background:

To strengthen the Regulatory Team, we are looking for an experienced person for a period of 6 months.
In this role, you will take independent responsibility for the regulatory verification and assessment of 3rd party products in relation to the applicable European (EU-MDR / EU-IVDR) and Swiss regulations (MepV / IvDV).
Tasks & Responsibilities:

• Regulatory Verification: Independent examination and assessment of technical documentation, declarations of conformity (DoC), CE certificates, and labeling of 3rd party medical devices and in-vitro diagnostics; verification of correct labeling regarding CH-REP (Swiss Authorized Representative) and importer obligations according to MepV/IvDV
• Vendor & Partner Management: Communication with suppliers and partners to request, review, and clarify missing regulatory evidence and quality agreements
• PRRC Support: Creation of recommendations for the release or blocking of 3rd party products for the Swiss market
• Operational support in the Regulatory area as needed: e.g., supplier inquiries, document review (non-exhaustive list)

Requirements:

• Successfully completed studies in the field of 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
• Sound knowledge
• Focus: Swiss In-vitro Diagnostics Ordinance (IvDV)
• Swiss Medical Devices Ordinance (MepV)
• Experience with 3rd-party processes: Practical experience in auditing, releasing, or verifying supplier and 3rd party documentation
• Business fluent German and English in spoken and written form

What is offered to you:

• A chance to contribute to one of the most significant pharmaceutical companies in the world
• Modern campus with lots of green spaces and meeting zones
• Central location with highway connection and train station nearby
• Varied activity profile
• Home office possibility
• Further training opportunities through temptraining
• Collaboration in a dynamic and motivated team

You are welcome to send your complete application documents to Ms. Diana Afonso.

Chemie Pharma Pharmacy Diagnostik Zug Luzern Verifikation Dokumentation Regulatory Affairs