International RA Manager Medical Devices
Gloor & Lang
- Chur, Grisons
- CDI
- Temps-plein
In the role of Manager Regulatory Affairs, you will be responsible for day-to-day business in the area of regulatory affairs for these medical devices.
- Compliance with regulatory requirements during conception and development, production, as well as during market observation of the products.
- Knowledge of normative and regulatory framework
- Application of standards (IEC 60601-1, ISO 80601-2-12, IEC 62304, etc.) to our products and processes
- International registration of medical devices worldwide, with a focus on the EU and US markets
- Education in a scientific or medical-technical direction.
- Experience in the field of regulatory affairs, ideally from medical technology
- Knowledge of the IEC 60601 or IEC 62304 series of standards
- Working independently, working in teams
- Cooperation and communication with authorities
- Languages: Fluent in English and German. Secure drafting of documents in English
- German: Motivation and willingness to learn the German language independently