Regulatory affairs specialist

PpYou have a first experience in Regulatory Affairs related to the life science industry? You are fluent in English and available ASAP? Apply now! /p 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 pAn amazing opportunity not to be missed! /p h3Responsibilities /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 liImmediate Availability /li liTrustful, Stress tolerant, Goal oriented Social /li /ul /p #J-18808-Ljbffr