You have a first experience in Regulatory Affairs to the life science industry? You are fluent in English and available ASAP? Apply now.Regulatory Affairs SpecialistAbout the roleFor our client, a major company, we are looking for a Regulatory Affairs Specialist to join their team! You will manage the compliance and product lifecycle of medical devices within a global framework. This role involves close collaboration with R&D and Marketing teams, the US, and Japan to ensure market access. The role focuses on ensuring all medical devices comply with regulations while managing the technical documentation and communication with health authorities throughout the product lifecycle. An amazing opportunity not to be missed!Interested in applying? Here is how:Apply to this job posting! Otherwise, we won't receive your application. Click HERE to take our personality test! It is required so we can process your application.Work tasks- Compile and submit dossiers and technical files to notified bodies and authorities.- Ensure systems and processes meet Medical Device Regulation (MDR) requirements.- Manage the lifecycle of products from development to market launch.- Perform assessments for product changes via change control processes.- Review and approve promotional materials and labeling to ensure compliance.- Handle reporting and data entry in the EUDAMED (UDI) database.- Support audits and inspections by providing required documentation to health authorities.We are looking for- Experience in regulatory affairs within the medical device or pharmaceutical industry.- Advanced knowledge of Medical Device Regulation (MDR).- Fluent English (C1 level).- Availability: ASAP.- Trustful, Stress tolerant, Goal oriented & Social.Our recruitment processThis recruitment process is handled by the recruitment agency and it is our client's wish that all questions regarding the position are directed to them. The selection process is continuous and the advert may close before the recruitment process is completed if we have moved forward to the next phase. The process includes two tests: one personality test and one cognitive test. The tests are tools to find the right talent for the right position, to enable equality, diversity, and a fair process. jid2b97a06aen jit0624aen jpiy26aen