Senior Regulatory Affairs Expert – Connected Medical Devices

Senior Regulatory Affairs Expert – Connected Medical Devices Switzerland – Bern Region | Hybrid / Flexible Home Office Permanent | Full-time Life-changing Medical Device Industry Are you passionate about regulatory strategy and want your work to directly impact patients lives? Were supporting a leading player in the medical device & digital health space , developing active and connected medical devices used globally in chronic disease management. This is a senior, influential role with strong exposure to the US market , FDA interactions , and cross-functional stakeholders. What You will Be Doing Play a key role in the development of innovative, connected medical devices Define, drive, and implement Regulatory Affairs strategies across product lifecycles Lead and support regulatory submissions , with a strong focus on the US / FDA Act as a trusted regulatory partner to R&D, Quality, Product, and Business teams Manage communications with regulatory authorities and support audits & inspections Contribute to Quality Management activities (Q-documents, training, compliance support) What Were Looking For 5+ years of Regulatory Affairs experience in the medical device industry Strong experience with the US market & FDA (strategic & operational level) Background in active and/or connected medical devices is a strong plus Solid understanding of regulatory frameworks in a global context Confident communicator, comfortable working with senior stakeholders Your Profile University degree in Engineering, Life Sciences, Medical or Natural Sciences (or similar) Structured, proactive, and collaborative mindset Fluent English (spoken & written), German is a strong advantage , but not mandatory Why This Role? Work in a meaningful industry where technology directly improves patients lives Be part of the connected & digital medical device evolution Enjoy excellent home-office flexibility Join a stable, innovative environment with long-term growth opportunities