Location:pEtoy /pStart date:pASAP /pExtent:pFull time, 80-100%, 6-month assignment /pType of work:pStaffing /pppbAbout the role /b /p /ppFor our client, a major multinational company, we are looking for a Regulatory Affairs Specialist to join their team ! You will manage the regulatory compliance and product lifecycle of medical devices within a global framework. This role involves close collaboration with RD and Marketing teams across Switzerland, the US, and Japan to ensure market access. /ppThis role focuses on ensuring that all medical devices comply with international regulations while managing the technical documentation and communication with health authorities throughout the product lifecycle. /p pAn amazing opportunity not to be missed ! /p pbInterested in applying? Here's how: /b /p libApply to this job posting! Otherwise, we won't receive your application. /b /li libClick to take our personality test! It's required so we can process your application /b /li ppbWork tasks /b /p /p liCompile and submit regulatory dossiers and technical files to notified bodies and international partners. /li liEnsure documentation and processes meet Medical Device Regulation (MDR) requirements. /li liManage the regulatory lifecycle of products from development through to market launch. /li liPerform regulatory impact assessments for product modifications via change control processes. /li liReview and approve promotional materials and labeling to ensure regulatory compliance. /li liManage Materiovigilance reporting and update the EUDAMED database (UDI implementation). /li liSupport audits and inspections by providing required documentation to health authorities. /li ppbWe are looking for /b /p /p liExperience in regulatory affairs within the medical device or pharmaceutical industry. /li liAdvanced knowledge of Medical Device Regulation (MDR). /li liFluent English (C1 level) /li liImmediate Availability /li liTrustful, Stress tolerant, Goal oriented Social /li ppbOur recruitment process /b /p /p pThis recruitment process is handled by Academic Work and it is our client’s wish that all questions regarding the position is directed to Academic Work. /p pOur 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. /pppbAvez-vous des questions à propos de ce poste? /b /p /p