Regulatory Affairs Manager

vor 1 Woche

Zurich, Schweiz agap2 - HIQ Consulting Vollzeit

agap2 is a dynamic and rapidly growing company and employs more than 6000 people in ten European countries. With more than 200 employees in Switzerland, we are specialized in Life Science, MedTech, Pharma, BioTech, etc. Our offices in Switzerland are located in Basel, Zürich, and Lausanne.

agap2 works successfully in all areas of the product life cycle, including Research & Development, Quality Management, Regulatory Affairs, Production, and Commercialization.

agap2 offers a permanent contract for highly qualified specialists with a background in engineering and life sciences for operative industry projects

Tasks
- International registration and approval of medical devices (various risk classes)
- Compilation of the relevant submission dossiers for international markets (e.g. USA, Canada, Middle East, Latin America, etc.)
- Maintaining and renewing registrations and approvals
- Post Market Surveillance and reporting to the corresponding authorities
- Participation in the group-wide implementation of regulatory requirements, such as the Medical Device Regulation (MDR) and international regulations
- Maintenance of the databases for the responsible medical devices worldwide
- Advising the specialist departments on the implementation of technical documentation and labeling

**Requirements**:

- Degree in natural sciences (e.g. pharmacy, chemistry, biology, toxicology) or engineering sciences (medical technology, biomedical technology) or corresponding professional experience of many years in these fields
- Team player, resilient and flexible personality with a high level of commitment and initiativekets
- Experience with FDA (510 (k)) & Health Canada is desirable
- Good oral and written communication skills in German and English
- Team player, resilient and flexible personality with a high level of commitment and initiative

**Benefits**:
You will have a technical manager at your side who will accompany, support, and prepare you for the next step of your career at agap2. Furthermore, you can expect a collegial team in a dynamic working atmosphere, extensive development opportunities, and the prospect of quickly taking on responsibility and actively shaping the future of the company.

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