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James Bonds Location
Woodstock, GA, US
James Bonds Work
2015 -now Director Regulatory Affairs @
2014 -2015 Director Regulatory Affairs @ Opti Medical Systems
2013 -2013 Director Regulatory Affairs @ BD Diagnostics
2010 -2013 Director Regulatory Affairs @
2007 -2010 Director Regulatory Affairs @ OrbusNeich Medical, Inc.
2002 -2007 Sr. Director Regulatory Affairs @ Tyco Healthcare/Covidien
2000 -2002 Vice President, QA and RA @ Sutura, Inc.
1995 -2000 Quality AssuranceGroup Manager @
James Bonds Education
Purdue Global Law School
J.D. (Law)
2007-2011
Augusta University
B.S. (Chemistry)
James Bonds Skills
Medical Devices
FDA
Regulatory Affairs
CAPA
Design Control
Regulatory Submissions
Quality System
GMP
V&V
Biotechnology
Validation
ISO 14971
PMA
Quality Assurance
Commercialization
Product Development
Clinical Trials
Regulatory Requirements
Sop
CE marking
Manufacturing
GLP
21 CFR Part 11
Clinical Development
Technology Transfer
Lifesciences
Biomedical Engineering
Change Control
Life Sciences
U.S. Food and Drug Administration (FDA)
ISO 13485
James Bonds Summary
James Bonds, based in Woodstock, GA, US, is currently a Director Regulatory Affairs at Facet Technologies LLC. James Bonds brings experience from previous roles at Opti Medical Systems, BD Diagnostics, Roche Molecular Systems and OrbusNeich Medical, Inc.. James Bonds holds a 2007 - 2011 J.D. in Law @ Purdue Global Law School. With a robust skill set that includes Medical Devices, FDA, Regulatory Affairs, CAPA, Design Control and more. James Bonds has 2 emails on RocketReach.
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