We have a current opportunity to join a global medical device manufacturer that are based in Switzerland and looking to expand their regulatory team.
Regulatory Affairs Manager
TASKS
International registration and approval of our medical devices (risk classes I, lla, IIb)
Assembling the relevant submission dossiers for international markets, especially for China
Maintaining and renewing registrations and approvals including market surveillance and reporting to the authorities
Collaboration in the group-wide implementation of regulatory requirements, such as the Medical Device Regulation (MDR) and international requirements (MDSAP)
Maintenance of the databases for the responsible medical devices worldwide
REQUIREMENTS
Studies in natural sciences (e.g. pharmacy, chemistry, biology, toxicology) or engineering sciences (medical technology, biomedical technology)
At least 3 years of experience in medical device registration in international markets
Experience with Asian markets (especially China) preferable
Good oral and written skills in German and English
Chemical background,experience with document management tools as well as SAP knowledge are an advantage
