Senior RA Specialist- Medical Devices

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My world leading class lll medical device client are looking for an RA specialist at senior level to help work on global regulatory documents, both assisting others as well as preparing technical files yourself for the EU and US. You will need little to no supervision so senior experience is needed. Day to day duties include;* Provides independent RA guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches. Inclusive of site transfer activities * Leads the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers.

Essential skills; * Practical experience with the preparation and submissions for Class II and III medical devices ( EU and USA) * Substantial experience of US, EU and International Regulations required* Leadership and senior level experience* Medical Device experience in class ll or lll or both Desirable skills* Knowledge of Additive manufacturing technology and associated regulations ( Software), advantageous* Experience working with submissions for Brazil, China, Japan and Russia prefered 40 hours fully on site in West Yorkshire£54 an hour To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales