Regulatory affairs specialist

Ph3bRegulatory Affairs Specialist /b /h3 h3About the role /h3 pFor 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. /p pThis 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 h3Work tasks /h3 ul 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 /ul h3We are looking for /h3 ul 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 /ul /p #J-18808-Ljbffr