Regulatory Affairs Specialist
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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
