Description
We are looking for a
Regulatory Affairs Engineer (m/f)
Referenz: -en
Beginn: asap
Dauer: 6 MM
Ort: in West Switzerland
Branche: Forschung und Entwicklung
Ihre Aufgaben:
- 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
Ihre Qualifikation
- 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
Skills:
- Regulatory affairs associate
Keywords: Regulatory Affairs Engineer Associate Assitant
Engineer or university degree preferably in electronics software or mechanics or in an equivalent scientific field biology chemistry etc freelance contractor freelancer contract contr contracting self-employed project Projekt