Speaker Profile


Grace Powers

BE in Biomedical Engineering

Consultant

Grace Powers is an independent regulatory affairs consultant. She founded Powers Regulatory Consulting in 2015 to help clients with regulatory strategies and submissions. Her clients have included universities, investors, start-ups and mid-size medical device companies. She has fifteen years of industry experience in medical devices including research and development. She has previously worked at Brookhaven Medical, Bard Medical, CardioMEMS and Novoste, all in the Atlanta area.

She has leadership experience with managing regulatory affairs responsibilities related to all pre- and post- marketing regulatory activities and submissions. Her RA submission experience includes 510(k), Pre-Submissions, IDE, PMA, EU Technical Files and Design Dossiers. She has also managed an International RA team which including Canadian licensing, TGA, Japan, China, Russia, Latin America and other country submissions. Grace holds an BE in Biomedical Engineering from Vanderbilt University, an MS in Biomedical Engineering from UCLA and an MBA from Georgia Tech. She is RAC US, RAC Europe, and RAC Global certified.

US FDA Pre-Submission process, IDE, 510(k), PMA and IVD
US FDA Pre-Submission process, IDE, 510(k), PMA and IVD

Speaker:Grace Powers
Time: 27th August 2018 10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Model : GRC-90378

Mon
27
Aug 2018

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