Regulatory Affairs Engineer (m/f)

- Assists the Regulatory Affairs Manager by providing support in compilation of technical

documentation - Compilation of technical documentation (writing of summary reports based on existing technical files and design dossiers) for all of our medical devices (disposables as well as contrast media delivery
system) - Support on international product registrations
- Assist to manage technical files of a new submission
- Assist to build technical files for China, Brazil and South Korea submission
- Actively support the Regulatory Affairs Manager
- Engineer or university degree preferably in electronics, software or mechanics or in an equivalent scientific field biology, chemistry etc.
- Profound work experience within a medical devices environment or in an equally well regulated environment
- Good working, regulatory and technical knowledge in electronics (electrical safety tests, EMC)
- Software validation, sterilization, biocompatibility, stability and aging
- Good writing skills to write technical summary report (in English)
- French nice to have, company language
- Rigorous and independent
- Immediately available

Weitere Qualifikationen: Regulatory affairs associate