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.

FDA PMA (PreMarket Approval)
FDA PMA (PreMarket Approval)

Speaker:Grace Powers
Time: 16th March 2019 10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Model : GRC-NR22

Sat
16
Mar 2019

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

Speaker:Grace Powers
Time: 17th April 2019 10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Model : GRC-90614

Wed
17
Apr 2019

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