Stellenbeschreibung

Regulatory Affairs Specialist – Basel –Permanent-  CHF 90.000+  My client is a top 5 medical devices company worldwide, with an impressive track-record and a pipeline with exciting new projects.They are 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 approvalsSupport 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 JapanIn charge of database and regulatory documents maintenanceOccasionally 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 advantageKnowledge of 510(k) and experience in Medical Devices RegulatoryFluency in English, knowledge of German highly desired The company is now developing new medical devices and they need specialists to help with new MAAs, but also focus on renewals and variations of current devices.