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 based 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 third-party products (3rd Party Products) with regard 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. 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, 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 required: 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: Demonstrable, multi-year (3+ years) professional experience in Regulatory Affairs / Quality Management in the medtech or IVD sector •Sound Knowledge: oEU-MDR (2017/745) and EU-IVDR (2017/746) oSwiss Medical Devices Ordinance (MepV) and In-vitro Diagnostic Regulation (IvDV) •Experience with 3rd-Party Processes: Practical experience in the auditing, release, or verification of supplier and third-party documentation •Business fluent German and English, both spoken and written Reference No.: 925169SBI Role: Verification & Compliance Specialist (m/f/d) Industry: Pharma Location: Rotkreuz Workload: 80-100% Start: ASAP Duration: 6 months Application Deadline: 26.08.2026 Should this position have 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 further information about our company, our positions, or our attractive Payroll-Only-Program: +41 41 760 77 01. About us: ITech Consult is an ISO 9001:2015 certified Swiss company with branches in Germany and Ireland. ITech Consult specializes in the placement of highly qualified candidates for personnel leasing in the fields 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.