2015 -2016 Vice President Clinical Regulatory Affairs @
2013 -2015 Senior Vice President, Regulatory and Clinical Affairs @ Channel Medsystems, Inc.
2012 -2013 VP, West Coast Operations @
2010 -2012 VP, Regulatory and Clinical Affairs @ Minerva Surgical
2009 -2010 Global VP, Regulatory @ Accelerated Clinical Research
2008 -2009 VP, Regulatory and Clinical Affairs @ Hansen Medical
2008 -2008 Interim Vice President and Consultant @
2005 -2007 Global VP-Regulatory Affairs @
2000 -2005 VP, RA and CA - Peripheral Vascular @
1979 -1994 Associate @ W. L. Gore & Associates
Mary Edwards Skills
Design Control
Medical Devices
Clinical Research
Management
Healthcare
Product Development
Orthopedic
Regulatory Submissions
CAPA
Quality System
Product Launch
Regulatory Requirements
ISO 13485
Biotechnology
Surgery
Regulatory Affairs
Lifesciences
Quality Assurance
Pharmaceutical Industry
Competitive Analysis
Biomedical Engineering
Capital Equipment
Cardiology
R&D
Validation
Clinical Trials
CRO
Clinical Development
Leadership
Operating Room
Commercialization
Market Development
FDA
Global Marketing
Health Economics
Cross-functional Team Leadership
V&V
CTMS
21 CFR Part 11
GCP
GMP
Oncology
Research and Development (R&D)
U.S. Food and Drug Administration (FDA)
CRO Management
Orthopedics
Life Sciences
Good Clinical Practice (GCP)
Women's Health
Clinical Trial Management System (CTMS)
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 Design Control, Medical Devices, Clinical Research, Management, Healthcare and more. Mary Edwards has 4 emails and 2 mobile phone numbers on RocketReach.
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