Senior Specialist Regulatory Affairs (a)

Darum lohnt es sich

For our site in Muntelier and/or Yverdon-les-Bains, we are looking for a /p h3Senior Specialist Regulatory Affairs (a) /h3 h3What we are looking for /h3 ul liLead the creation and maintenance of Technical Documentation throughout the product development lifecycle /li liOwn regulatory strategy and compliance activities across the entire product lifecycle /li liManage CE marking activities under MDR and FDA regulatory submissions /li liEnsure regulatory compliance and product registrations in international markets /li liLead Post-Market Surveillance (PMS), vigilance, and market monitoring activities /li liAct as the primary liaison with notified bodies, regulatory authorities, and external partners /li liMonitor evolving regulatory requirements and drive their implementation within the Quality Management System /li liPartner closely with RD, Quality Assurance, Clinical Affairs, and other stakeholders to support product development and market access /li /ul h3What makes you a great fit /h3 ul liDegree in Engineering, Life Sciences, or a related field, combined with several years of Regulatory Affairs experience in the medical device industry /li liStrong knowledge of European MDR and U.S.

FDA regulations, including regulatory submissions and technical documentation /li liSolid understanding of clinical evaluation, biocompatibility, quality management systems, and regulatory compliance processes /li liFluent in German and English, both written and spoken, French is considered an asset /li liWillingness to travel within Europe and the US /li liStructured, proactive, and solution-oriented professional with a high level of ownership and accountability /li liExcellent communication and stakeholder management skills, with the ability to translate complex regulatory requirements into practical business solutions /li /ul h3Why you’ll love working with us /h3 ul liAn open company culture, short decision-making processes, and an open-door philosophy /li li6 weeks of vacation /li liAttractive social benefits /li liOpportunities for individual development /li liRegular team events /li liLoyalty bonuses /li /ul /p #J-18808-Ljbffr ppElos Medtech is one of the world’s leading development and manufacturing partners for companies in the medical technology sector.

With sites in Switzerland, Sweden, Denmark, Germany, China, and the United States, we specialize in the production of implants, instruments, and components for medical technologies. /p pWe are looking for individuals who share our values — passion, trust, and results — so we can grow together and achieve even greater success.

If you are ready to give your best and join an environment that values collaboration and commitment, we look forward to receiving your application.