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 @
Director Quality Assurance (acting) @ (February 2000 - December 2000)
Regulatory Affairs Coordinator @
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)
Harvey Grammar School
Canterbury College of Technology
ONC Chemistry
Ian Hooper Skills
Regulatory Affairs
Medical Devices
FDA
ISO 13485
GMP
Quality Assurance
Validation
Change Control
CAPA
Regulatory Submissions
Design Control
Lifesciences
Quality Control
PMA
V&V
IVD
Team Management
Life Sciences
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 Regulatory Affairs, Medical Devices, FDA, ISO 13485, GMP and more. Ian Hooper has 2 emails on RocketReach.
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