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Senior Regulatory Scientist, Medical Devices and in Vitro Diagnostic Medical Devices (IVDs) | Lausanne

Lausanne

 

Senior Regulatory Scientist, Medical Devices and in Vitro Diagnostic Medical Devices (IVDs)

Under the supervision of senior management:

  • Write, review and assemble high quality regulatory submissions for medical devices and IVDs, such as CE marking dossier and CTA dossier/IB for clinical trials in Europe, Premarket Approval Application (PMA), Premarket notification (510k), De Novo submission and Investigational Device Exemptions (IDEs), totally or partially, as need be,
  • Participate to any other relevant projects of the product line such as regulatory strategy, positioning and roadmaps, trainings to clients etc…
  • Ensure compliance of deliverables with EU and US or other territory regulations and applicable guidelines
  • Communicate clearly with clients as well as with regulatory authorities for assigned projects
  • Monitor, prioritize and supervise project strategy, timelines, and milestones and communicate them to the project team members

Complimentary activities:

  • Participate as requested and per directions from Senior management in pre-project tasks for EU, US and RoW scopes of works (incl. proposals for assistance drafting to prospects)
  • Attend and present at conferences and/or write articles in your area of expertise

Required

  • Degree Life Science or equivalent
  • 2+ years experience
  • Ambition to build a career in Life Science

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