Verification & Compliance Specialist

Verification & Compliance Specialist: Regulatory Affairs / Quality Management / Medtech / IVD sector / MepV / IvDV / Verification English / German

Background:

To strengthen our regulatory team, we are looking for an experienced external contractor (m/f/d) for a period of 6 months.

In this role, you will take on the independent regulatory verification and assessment of third-party products in relation to the applicable European (EU-MDR / EU-IVDR) and Swiss regulations (MepV / IvDV).

The perfect candidate is a qualified professional with a degree in medical technology, natural sciences, or industrial engineering. The person brings at least three years of experience in Regulatory Affairs or Quality Management in the medtech/IVD industry. Sound knowledge of the EU-MDR/IVDR as well as the Swiss MepV/IvDV are required, as is practical experience in the verification of third-party documentation. Very good German and English skills complete the profile.

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 third-party products for the Swiss market.
• Operational support in the regulatory area as needed: supplier inquiries, document review (non-exhaustive list)

Must Haves:

• 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 Diagnostic Regulation (IvDV)
• Swiss Medical Devices Ordinance (MepV)
• Experience with 3rd-party processes: Practical experience in auditing, releasing, or verifying supplier and third-party documentation
• Business fluent German and English in speaking and writing

Reference Nr.: 925264
Role: Verification & Compliance Specialist
Industry: Pharma
Location: Rotkreuz
Workload: 80 - 100%
Start:
Duration: 12 + Months
Deadline:

If this position has piqued your interest, please send us your complete resume. If this position does not quite match your profile and you would like to receive other positions directly, you can also send us your resume via this ad or to jobs[at]itcag[dot]com.

Contact us for more information about our company, our positions, or our attractive payroll-only program: .

About us:

ITech Consult is an ISO 9001:2015-certified Swiss company with offices in Germany and Ireland. ITech Consult specializes in placing highly qualified candidates for temporary staffing in the fields of IT, life sciences, and engineering. We offer temporary staffing and payroll services. This is free of charge for our candidates, and we do not charge any additional fees for payroll services.

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