Verification & Compliance Specialist

About the job

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
• Work model: On-site
• Working hours: Regular business hours
• Team: 7 people
• Languages: Fluent German and English

Requirements:

• Independent regulatory review and assessment of third-party medical devices and in vitro diagnostics according to applicable Swiss and European requirements, especially EU MDR, EU IVDR, MepV and IvDV
• Review of technical documentation, declarations of conformity (DoC), CE certificates, product labelling and other regulatory documents
• Ensuring correct labelling and documentation regarding CH-REP as well as importer obligations according to MepV and IvDV
• Review of third-party and supplier documentation for regulatory compliance and completeness
• Direct communication with suppliers and external partners to obtain, review and clarify missing regulatory evidence and quality agreements
• Support of PRRC activities by preparing recommendations for 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 review of regulatory documents

Competences:

• Completed studies in 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 Diagnostic Ordinance (IvDV)
• Sound knowledge of the Swiss Medical Devices Ordinance (MepV)
• Good knowledge of EU MDR and EU IVDR
• Practical experience with third-party processes, especially in auditing, release or verification of supplier and third-party documentation
• Experience in reviewing technical documentation, declarations of conformity, CE certificates and product labelling
• Independent and structured working style as well as confidence in collaborating with suppliers, partners and internal stakeholders
• Fluent German and English skills in spoken and written form
• A completed vocational or university education is mandatory