Grace Powers

    Grace founded Powers Regulatory Consulting in July 2017. She has fifteen years experience in cardiology and urology medical devices including R&D.  She has management experience including RA responsibilities related to submissions and compliance.  Her RA submission experience includes 510(k), IDE, PMA, HUD, EU Technical Files and Design Dossiers.

    She previously has managed an International RA team which including Canadian licensing, Australia, Japan, China, Russia, Latin America and other country submissions.

    She has worked for Brookhaven Medical, C.R. Bard, CardioMEMS and Novoste.  She also does regulatory consulting for universities, inventors and start-ups.  Grace holds a BE in Biomedical Engineering from Vanderbilt University, a MS in Biomedical Engineering from UCLA and an MBA from Georgia Tech. She is RAC US, RAC Europe, and RAC Global certified.