Head of Notified Body @ (July 2017 - October 2018)
Head, Global Quality and Regulatory Program Management @ (June 2016 - May 2017)
Director, Regulatory Affairs and Quality Assurance (Head), International Sales Organisation @ (April 2010 - May 2016)
Director, Regulatory Affairs @ (July 2007 - March 2010)
Manager, International Regulatory Affairs @ (January 2001 - January 2007)
Director Quality Assurance (acting) @ (February 2000 - December 2000)
Regulatory Affairs Coordinator @ (January 1998 - January 2000)
Manager, Quality Assurance @ Trinity Biotech / Centocor UK (January 1993 - January 1998)
Ian Hooper Education
Cranfield University
MSc (Medical Technology Regulatory Affairs)
2006-2009
The Open University
BA (Hons) (Sciences)
1985-1990
Bromley College of Technology
HNC Applied Biology (Industrial Microbiology)
Canterbury College of Technology
ONC Chemistry
Harvey Grammar School
Ian Hooper Skills
CAPA
Change Control
Design Control
FDA
GMP
ISO 13485
IVD
Life Sciences
Lifesciences
Medical Devices
PMA
Quality Assurance
Quality Control
Regulatory Affairs
Regulatory Submissions
Team Management
U.S. Food and Drug Administration (FDA)
V&V
Validation
Change Management
Pharmaceutical Industry
Data Validation
Microsoft Excel
Engineering
Process Improvement
Strategy
International Sales
Training
Microsoft Office
Product Quality
Marketing
RAD
u.s. Food and Drug Administration Fda
u.s. Food and Drug Administration
Ian Hooper Summary
Ian Hooper, based in Aldenham, England, GB, is currently a Director, Regulatory Affairs and Quality Assurance at GAMA Healthcare Ltd. Ian Hooper brings experience from previous roles at SGS, Bio-Rad Laboratories and Ortho Clinical Diagnostics. Ian Hooper holds a 2006 - 2009 MSc in Medical Technology Regulatory Affairs @ Cranfield University. With a robust skill set that includes CAPA, Change Control, Design Control, FDA, GMP and more. Ian Hooper has 2 emails on RocketReach.
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