Regulatory Affairs Specialist

Regulatory Affairs Specialist Strengthen a leading diagnostics company in Rotkreuz as a Regulatory Affairs Specialist and ensure that medical devices and IVDs from third-party providers meet all EU regulations. Regulatory Affairs Specialist Job description: For our client, a leading international company from the diagnostics and healthcare industry, we are looking for an experienced Regulatory Affairs Contractor to strengthen the team in Rotkreuz. The focus of the position is on the independent regulatory verification and assessment of third-party medical devices and in-vitro diagnostics (IVD) according to the applicable European and Swiss regulatory requirements. About the customer: Start: ASAP Duration: 6 months Work location: Rotkreuz, Switzerland Workload: 100% Team: 7 people Requirements: Independent regulatory review and assessment of third-party medical devices and in-vitro diagnostics according to EU MDR, EU IVDR, MepV and IvDV. Review of technical documentation, declarations of conformity (DoC), CE certificates, product labeling and other regulatory evidence. Verification of correct labeling for the market, especially regarding CH-REP (Authorized Representative) as well as importer obligations according to MepV/IvDV. Direct communication with suppliers and external partners to request, review and clarify missing regulatory evidence and quality agreements. Review and verification of supplier and third-party documentation within the framework of release and compliance processes. Support of the Person Responsible for Regulatory Compliance (PRRC) by creating recommendations for the release or blocking of third-party products for the market. Operational support in the field of Regulatory Affairs as needed, for example with supplier inquiries and the review of regulatory documentation. Competences: Successfully 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 practical knowledge of EU MDR (2017/745) and EU IVDR (2017/746). Sound knowledge of the Medical Devices Ordinance (MepV) and In-vitro Diagnostics Ordinance (IvDV). Practical experience with 3rd-party processes, especially in the auditing, release and/or verification of supplier and third-party documentation. Experience in the review of technical documentation, declarations of conformity, CE certificates and product labeling is a great advantage. Independent and structured way of working as well as the ability to carry out regulatory assessments and recommendations independently. Business fluent German and English skills in speaking and writing. jpid80eb82ejm jit0834jm jiy26jm