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