Regulatory Affairs Specialist
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- 210005GM Numéro de demande de personnel
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- Mar 01, 2021 Date de publication
Merci de votre intérêt pour le poste de Regulatory Affairs Specialist. Malheureusement, le poste est comblé, mais vous pouvez effectuer une recherche dans nos 1,349 emplois vacants en cliquant ici.
Basic Qualifications:
Master’s degree in Regulatory Affairs/Science, Biomedical Engineering, Pharmacy or related medical clinical field and 6 months of experience in regulatory affairs*. Must possess a minimum of 6 months of experience* with each of the following: Preparing and reviewing pre and post market regulatory submissions for Class II and Class III medical devices in U.S. and EU; U.S. and EU Class II and Class III device regulations and reportability for product changes; medical device submissions and clearances including FDA medical device regulations and EU Medical Device Directive 2007/47/EC; developing strategies for regulatory approval in U.S., EU, Japan, and Brazil; worldwide regulatory requirements 510(k), IDE and PMA device product submissions; 21 CFR 11, 800, 801, 803, 806, 807, 809, 820, ISO 13485 and ISO 14971. *Experience maybe gained through internships, research, coursework and/or work experience
