Founder and Principal Consultant @ Powers Regulatory Consulting (July 2017 - Present)
Vice President Regulatory Affairs @ Brookhaven Medical, Inc. (November 2015 - July 2017)
Regulatory Affairs Consultant @ G Powers, LLC (January 2015 - January 2017)
Associate Director Regulatory Affairs @ (February 2015 - October 2015)
Senior Regulatory Affairs Manager - International and Operations @ (August 2014 - February 2015)
Regulatory Affairs Manager @ (August 2012 - July 2014)
Senior Regulatory Affairs Specialist @ (July 2011 - August 2012)
Regulatory Affairs Specialist II @ (March 2010 - June 2011)
Vice President, Marketing @ Belle Curves, LLC (January 2010 - January 2012)
Senior Regulatory Affairs Specialist @ (August 2009 - March 2010)
Regulatory Affairs Specialist @ (November 2006 - August 2009)
Senior Biomedical Engineer @ (November 2004 - November 2006)
Biomedical Engineer @ (August 2003 - November 2004)
Associate Engineer @ (March 2002 - February 2003)
Grace Powers Education
Georgia Tech Scheller College of Business
MBA (Evening )
2007-2010
UCLA
MS (Biomedical Engineering)
2000-2001
Vanderbilt University
BE (Biomedical Engineering)
1996-2000
North Springs High School 1992-1996
Grace Powers Skills
FDA
Medical Devices
Regulatory Affairs
Biomedical Engineering
ISO 13485
Design Control
CE marking
PMA
R&D
Quality System
Clinical Trials
V&V
Product Development
Regulatory Submissions
Commercialization
21 CFR
FDA GMP
Medical Device Directive
Software Documentation
Regulatory Requirements
Global Regulatory Strategy
IDE
MDRs
Project Planning
510(k)
HUD
International Regulations
Global Regulatory Compliance
Regulatory Documentation
Pre-clinical Studies
Defining Product Requirements
U.S. Food and Drug Administration (FDA)
Premarket Approval (PMA)
Research and Development (R&D)
Verification and Validation (V&V)
Consulting
Social Justice
Public Speaking
Needs Analysis
510K
Verification And Validation V&V
Sales
Behavioral Health
Crisis Intervention
Regulatory
Universities
Mental Health
Business Development
Fundraising
Engineering
Premarket Approval Pma
Research And Development R&D
Microsoft Office
Case Management
Marketing
Nonprofits
Program Evaluation
Community Outreach
U.S. Food And Drug Administration Fda
Program Development
Treatment
Psychotherapy
Community Mental Health
Mental Health Counseling
Social Services
Pre Clinical Studies
Research
Advocacy
Biopsychosocial Assessments
Java
Project Management
Strategy
u.s. Food and Drug Administration
Premarket Approval
Research and Development
Verification and Validation
Grace Powers Summary
Grace Powers, based in Atlanta, GA, US, is currently a Lecturer- Regulatory Requirements for Biomedical Engineering at Georgia Institute of Technology. Grace Powers brings experience from previous roles at Powers Regulatory Consulting, Brookhaven Medical, Inc., G Powers, LLC and CR Bard. Grace Powers holds a 2007 - 2010 MBA in Evening @ Georgia Tech Scheller College of Business. With a robust skill set that includes FDA, Medical Devices, Regulatory Affairs, Biomedical Engineering, ISO 13485 and more. Grace Powers has 1 emails and 1 mobile phone numbers on RocketReach.
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