Mary Edwards Email & Phone Number
Founder and President
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Mary Edwards Location
- Irvine, CA, US
Mary Edwards Work
- Founder and President @ Edwards Consulting (April 2023 - Present)
- Senior Vice President, Regulatory Affairs (Special Projects) @ (January 2017 - May 2023)
- Vice President Clinical Regulatory Affairs @ (July 2015 - December 2016)
- Senior Vice President, Regulatory and Clinical Affairs @ Channel Medsystems, Inc. (September 2013 - July 2015)
- VP, West Coast Operations @ (August 2012 - August 2013)
- VP, Regulatory and Clinical Affairs @ Minerva Surgical (May 2010 - April 2012)
- Global VP, Regulatory @ Accelerated Clinical Research (April 2009 - May 2010)
- VP, Regulatory and Clinical Affairs @ Hansen Medical (January 2008 - January 2009)
- Interim Vice President and Consultant @ (January 2008 - June 2008)
- Global VP-Regulatory Affairs @ (January 2005 - January 2007)
- VP, RA and CA - Peripheral Vascular @ (January 2000 - January 2005)
- Associate @ W. L. Gore & Associates (January 1979 - January 1994)
Mary Edwards Skills
- 21 CFR Part 11
- Biomedical Engineering
- Biotechnology
- CAPA
- CRO
- CRO Management
- CTMS
- Capital Equipment
- Cardiology
- Clinical Development
- Clinical Research
- Clinical Trial Management System (CTMS)
- Clinical Trials
- Commercialization
- Competitive Analysis
- Cross-functional Team Leadership
- Design Control
- FDA
- GCP
- GMP
- Global Marketing
- Good Clinical Practice (GCP)
- Health Economics
- Healthcare
- ISO 13485
- Leadership
- Life Sciences
- Lifesciences
- Management
- Market Development
- Medical Devices
- Oncology
- Operating Room
- Orthopedic
- Orthopedics
- Pharmaceutical Industry
- Product Development
- Product Launch
- Quality Assurance
- Quality System
- R&D
- Regulatory Affairs
- Regulatory Requirements
- Regulatory Submissions
- Research and Development (R&D)
- Surgery
- U.S. Food and Drug Administration (FDA)
- V&V
- Validation
- Women's Health
- Clinical Trial Management System Ctms
- Sales
- Regulatory
- Good Clinical Practice Gcp
- Business Analysis
- Strategic Planning
- Research And Development R&D
- Microsoft Office
- Cross Functional Team Leadership
- Change Management
- Clinical Affairs
- U.S. Food And Drug Administration Fda
- Project Management
- Research
- u.s. Food and Drug Administration
- Research and Development
- Good Clinical Practice
- Clinical Trial Management System
Mary Edwards Summary
- Mary Edwards, based in Irvine, CA, US, is currently a Founder and President at Edwards Consulting. Mary Edwards brings experience from previous roles at Edwards Lifesciences, Direct Flow Medical®, Inc., Channel Medsystems, Inc. and Regulatory & Clinical Research Institute, Inc.. With a robust skill set that includes 21 CFR Part 11, Biomedical Engineering, Biotechnology, CAPA, CRO and more. Mary Edwards has 3 emails and 2 mobile phone numbers on RocketReach.
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