Verification & Compliance Specialist

For an exciting Regulatory Affairs position in the MedTech and IVD environment in Rotkreuz, we are looking for an experienced specialist for a…

Verification & Compliance Specialist

Job description:

For an exciting Regulatory Affairs position in the MedTech and IVD environment in Rotkreuz, we are looking for an experienced specialist for a 6-month project assignment. The focus is on the regulatory verification and assessment of third-party medical devices and in-vitro diagnostics for the Swiss market.

About the customer:

• Location: Rotkreuz, Switzerland
• Workload: 80-100%
• Contract duration: 6 months
• Start: ASAP
• Working model: On-site
• Working hours: Regular business hours
• Team: 7 people
• Languages: Fluent German and English

Requirements:

• Independent regulatory examination and assessment of third-party medical devices and in-vitro diagnostics according to the applicable Swiss and European requirements, in particular EU MDR, EU IVDR, MepV and IvDV
• Examination of technical documentation, declarations of conformity (DoC), CE certificates, product labeling and other regulatory documents
• Ensuring correct labeling and documentation regarding CH-REP as well as importer obligations according to MepV and IvDV
• Examination of third-party and supplier documentation for regulatory compliance and completeness
• Direct communication with suppliers and external partners to obtain, examine and clarify missing regulatory evidence and quality agreements
• Support of PRRC activities through the creation of recommendations for the release or blocking of third-party products for the Swiss market
• Operational support in the Regulatory Affairs area as needed, for example with supplier inquiries and the examination of regulatory documents

Competences:

• Completed studies in the field of medical technology, natural sciences, industrial engineering or a comparable qualification
• At least 3 years of professional experience in Regulatory Affairs and/or Quality Management within the MedTech or IVD industry
• Sound knowledge of the Swiss In-vitro Diagnostics Ordinance (IvDV)
• Sound knowledge of the Swiss Medical Devices Ordinance (MepV)
• Good knowledge of the EU MDR and EU IVDR
• Practical experience with third-party processes, especially in auditing, releasing or verifying supplier and third-party documentation
• Experience in examining technical documentation, declarations of conformity, CE certificates and product labeling
• Independent and structured way of working as well as confidence in working with suppliers, partners and internal stakeholders
• Business fluent German and English skills in spoken and written form
• A completed professional or university education is mandatory

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