Position: Regulatory Project Lead (60%, 6-month mandate)
Location: Lausanne, EPFL Innovation Park
Start date: As soon as possible
Workload: 60%
We are seeking a Regulatory Project Lead to support the preparation of two upcoming clinical studies involving novel, unregulated medical devices. This is a 6-month mandate requiring close collaboration with internal product development team, Swiss regulatory authorities, and the hospital teams in Switzerland and Germany conducting the studies.
Key responsibilities include:
- Leading regulatory preparation and documentation for two upcoming clinical studies.
- Liaising with Swissmedic, ethics committees, and clinical partners.
- Ensuring alignment between regulatory strategy, product development, and clinical operations.
- Participating in biweekly in-person meetings with the Xsensio team in Lausanne.
- Supporting the team in implementing QMS.
Required qualifications:
- Proven experience with clinical studies for an unregulated medical device in Switzerland and/or Germany.
- Familiarity with Swiss regulations and ethics submissions for unregulated devices.
- Strong communication and coordination skills across technical and clinical teams.
- Fluency in English and French.