Michael Schefke, MS, is a Regulatory Affairs Specialist III with extensive experience in global regulatory affairs and quality assurance within the medical device and diagnostic industries. With 6 years of proven success, Michael has led numerous pre-market submissions, including 510(k) and Emergency Use Authorizations, and developed post-market surveillance programs. Currently employed at Hologic, Inc., Michael previously held positions at Fluxergy, NEUROVASC Technologies, and Zimmer Biomet, where they demonstrated exceptional leadership and project management skills. Michael earned a Master of Science in Regulatory Science from the University of Southern California and a Bachelor’s degree in Exercise and Sport Science from the University of North Carolina at Chapel Hill.
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