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
* Strongexperience 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
#J-18808-Ljbffr