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.

• Play a key role in the development of innovative, connected medical devices
• Define, drive, and implement Regulatory Affairs strategies across product life cycles
• 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)

• 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

• 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

• 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