Quality, Regulatory, EH and S @ (January 2004 - January 2005)
Regulatory Affairs @ (January 2002 - January 2004)
Steve James Education
Irish Management Institute 2008-2009
Newcastle University
Master's of Research
2000-2001
University of South Wales
Bachelor of Science - BS
1997-2000
Steve James Skills
Regulatory Affairs
ISO 13485
Regulations
Medical Devices
People Development
Design Control
FDA
Organizational Leadership
Quality System
V&V
GMP
Cross-functional Team Leadership
Clinical Trials
Regulatory
ISO 14971
u.s. Food and Drug Administration Fda
Verification and Validation V&V
Marketing
Microsoft Office
Research
Cross Functional Team Leadership
Verification and Validation
u.s. Food and Drug Administration
Steve James Summary
Steve James, based in Irvine, CA, US, is currently a WW VP, Regulatory Affairs at Johnson & Johnson MedTech. Steve James brings experience from previous roles at Edwards Lifesciences and Boston Scientific. Steve James holds a 2008 - 2009 Irish Management Institute. With a robust skill set that includes Regulatory Affairs, ISO 13485, Regulations, Medical Devices, People Development and more. Steve James has 3 emails and 2 mobile phone numbers on RocketReach.
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