Vice President, Regulatory and Quality Affairs @ Galvanize Therapeutics, Inc. (Previously Gala Therapeutics, Inc.) (January 2018 - June 2020)
Regulatory Affairs Consultant @ Galvanize Therapeutics, Inc. (Previously Gala Therapeutics, Inc.) (January 2016 - December 2017)
Head of Quality Systems, Clinical and Regulatory Affairs (Contract) @ (January 2013 - December 2017)
Vice President, Clinical, Regulatory and Quality (Contract) @ Kona Medical USA (January 2010 - January 2013)
Vice President, Regulatory and Clinical Affairs @ Northstar Neuroscience, Inc. (NASDAQ: NSTR) (January 2007 - May 2009)
Director, Regulatory and Quality @ (August 2002 - February 2007)
Director, Clinical, Regulatory, Quality @ CoAptus Medical Corporation (January 2005 - January 2007)
Director, Quality Systems @ (July 1995 - April 2002)
New Product Development Manufacturing Engineer @ (January 1986 - January 1992)
Deborah Sheffield Education
University of Cincinnati College of Nursing 1999-2001
Oakland University 1987-1988
Rutgers University 1986-1987
Kettering University 1981-1986
Deborah Sheffield Skills
Six Sigma
Quality Management
E Commerce
Design Control
Clinical Trials
Business Commerce Network
Neurostimulation
International Trade
B2B
GMP
ISO
Building Business Partnerships
Start Ups
Biomedical Engineering
Clinical Research
Sourcing
Biotechnology
Business Development
Regulatory Affairs
Validation
Medical Devices
Quality Assurance
Renal Denervation
Quality System
V&V
Quality Auditing
Cross Functional Team Leadership
Custom Software Development
CE marking
Regulatory Submissions
Software Outsourcing
Product Development
Product Launch
Internet
CAPA
FDA
R&D
Global Clinical Trial Research
21 CFR Part 11
ISO 13485
Deborah Sheffield Summary
Deborah Sheffield, based in Seattle, WA, US, is currently a Chief Regulatory Officer at Galvanize Therapeutics, Inc.. Deborah Sheffield brings experience from previous roles at Sheffield Biomedical Consulting, Galvanize Therapeutics, Inc. (Previously Gala Therapeutics, Inc.) and Nativis Inc.. Deborah Sheffield holds a 1999 - 2001 University of Cincinnati College of Nursing. With a robust skill set that includes Six Sigma, Quality Management, E Commerce, Design Control, Clinical Trials and more. Deborah Sheffield has 3 emails and 2 mobile phone numbers on RocketReach.
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