Stellenbeschreibung

Senior Regulatory Affairs Specialist Medical Devices -Basel-Permanent-CHF 130.000 I am currently recruiting for a globally renowned Medical Devices company who is looking for a Senior Regulatory Affairs Specialist to join their team in the Regulatory Affairs R&D Department near Basel. Responsibilities:•Prepare and submit 510(k) Premarket Notification, PMA, IDE, and Design Dossier submissions•Create and maintain Essential Requirements Checklists, CE Technical Files and Declarations of Conformity for all products bearing the CE Marking.•Review variations for product changes and/or modifications related to manufacturability•Review technical literature (labeling, patient guides, etc.), sales and marketing literature, and reimbursement literature related to company products.Requirements:•A good degree in Science or Engineering from an accredited college or university.  A minimum of 5 years direct experience in regulatory affairs (preferably in the medical device area)•Excellent knowledge of international regulatory compliance requirements: FDA, PMA, 510(k) Notifications, Medical Device Directive, and European Standards.•Professional knowledge of English and German  The company has an impeccable international track record If you believe that this role suits your abilities and your previous experience, then don’t hesitate to apply.