Regulatory Affairs Manager

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