Regulatory Affairs Consultant - Swiss MepV/IvDV - 7107 URA

pbRegulatory Affairs Consultant - Swiss MepV/IvDV - 7107 URA /b /ppOur client is a leading Swiss multinational healthcare company headquartered in Basel, Switzerland. Operating in Pharmaceuticals and Diagnostics, it is one of the world's largest biotech companies and a global leader in in-vitro diagnostics and cancer treatments. Our client is known for its strong focus on innovation, particularly in personalized healthcare, and has played a major role in developing treatments for oncology, immunology, infectious diseases, and neuroscience. /ppThe ideal candidate is a qualified bGerman speaking /b professional with a degree in medical technology, natural sciences, or industrial engineering. They will have at least three years of experience in regulatory affairs or quality management within the medtech/IVD industry. Sound knowledge of the Swiss In Vitro Diagnostics Ordinance (IvDV) bSwiss Medical Devices Ordinance (MepV) /b and practical experience in verifying third-party documentation. This is a b6 months contract role /b to be working from their office in Rotkreuz in Switzerland. /ph3Main Responsibilities /h3ulliRegulatory Verification: Independent review and evaluation of technical documentation, Declarations of Conformity (DoC), CE certificates, and markings for third-party medical devices and in-vitro diagnostics; verification of correct labeling with regard to CH-REP (Swiss Authorized Representative) and importer obligations In accordance with MepV/IvDV. /liliVendor Partner Management: Communication with suppliers and partners to request, review, and clarify missing regulatory documentation and quality agreements. /liliPRRC Support: Preparation of recommendations for the approval or blocking of third-party products for the Swiss market. /liliOperational support in the area of regulatory affairs as needed: e.g., supplier inquiries, document review (non-exhaustive list) /li /ulh3Qualifications and Experience: /h3ullibRelevant Swiss working/residency permit or Swiss/EU-Citizenship required /b /liliSuccessfully completed degree in medical technology, natural sciences, industrial engineering, or a comparable qualification /liliRegulatory expertise: Demonstrable, several years (3+ years) of professional experience in regulatory affairs/quality management in the medtech or IVD sector /liliGood Knowledge of: /liliSwiss Medical Devices Ordinance (MepV) and In Vitro Diagnostics Ordinance (IvDV) /liliExperience with third-party processes: Practical experience in auditing, approving, or verifying supplier and third-party documentation /liliFluent German and English, both written and spoken /li /ul #J-18808-Ljbffr