Stellenbeschreibung

Regulatory Affairs Specialist – Basel –Permanent- €90.000   I am currently recruiting for a global medical device company looking for a Regulatory Affairs Specialist to join their team near Basel. Ideally, the candidate will be bilingual in English and German and has around 3 years’ experience in Medical Devices, particularly Class II and III.   Responsibilities: ·         Offer support in the development process and CE documentation: Labeling, review and approval. ·         Work along with the Regulatory team in obtaining US FDA 510(k) and other approvals ·         Support the management by performing various Regulatory tasks for the company products. ·         Liaise with the other departments of the company, such as: the R&D, Marketing, Customer Service, Production and IT. ·         Work on getting EU and ROW registrations, excluding Japan ·         In charge of database and regulatory documents maintenance ·         Occasionally delegate tasks to more Junior Regulatory Affairs Specialists, and train or coach them if needed. Requirements: ·         A good University degree in a relevant Life Sciences/Medical Devices subject. Candidates with postgraduate degrees will have an advantage ·         Knowledge of 510(k) and experience in Medical Devices Regulatory ·         Fluency in English, knowledge of German highly desired   The company is now developing new medical devices and they need specialists to help with new MAs, but also focus on renewals and variations of current devices.