Verification & Compliance Specialist

Verification & Compliance Specialist (m/f/d) Verification & Compliance Specialist (m/f/d) - EU-MDR / EU-IVDR / MepV / German / English Project: For our client Roche Diagnostics Schweiz located in Rotkreuz, we are looking for a Verification & Compliance Specialist (m/f/d) Verification & Compliance Specialist (m/f/d) Verification & Compliance Specialist (m/f/d) - EU-MDR / EU-IVDR / MepV / German / English Project: For our client Roche Diagnostics Schweiz located in Rotkreuz, we are looking for a Verification & Compliance Specialist (m/f/d) 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 independent responsibility for the regulatory verification and assessment of 3rd Party Products with regard to the applicable European (EU-MDR / EU-IVDR) and Swiss regulations (MepV / IvDV). The perfect candidate is a qualified specialist 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 EU-MDR/IVDR as well as the Swiss MepV/IvDV are prerequisites, as is practical experience in the verification of 3rd party documentation. Very good German and English skills round off the profile. Main tasks and areas of responsibility: 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, checking the correct labeling regarding CH-REP (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 market. Operational support in the Regulatory area as needed: e.g., 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: Proven, multi-year (3+ years) professional experience in Regulatory Affairs / Quality Management in the medtech or IVD sector Sound Knowledge: EU-MDR (2017/745) and EU-IVDR (2017/746) Medical Devices Ordinance (MepV) and In-vitro Diagnostics Ordinance (IvDV) Experience with 3rd-party processes: Practical experience in auditing, releasing, or verifying supplier and 3rd party documentation Business fluent German and English in speaking and writing Reference No.: 925169SBI Role: Verification & Compliance Specialist (m/f/d) Industry: Pharma Location: Rotkreuz Workload: 80-100% Start: ASAP Duration: 6 months Application Deadline: If this position has piqued your interest, please send us your complete [application]. If this position does not fit your profile so well and you wish to receive other positions directly, you can also send us your dossier via this advertisement 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 company with branches in Germany and Ireland. ITech Consult specializes in the placement of highly qualified candidates for personnel leasing in the areas of IT, Life Science & Engineering. We offer personnel leasing & payroll services. For our candidates, this is free of charge; even for payroll, we do not charge you any additional fees. jpid676eeaejm jit0834jm jiy26jm