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Declan Hynes Location
Cardiff, GB
Declan Hynes Work
2016 -now Senior Regulatory Affairs Manager @
2012 -2016 Senior Regulatory Affairs Leader @
2005 -2012 Regulatory Associate @
1995 -2005 Scientist @
Declan Hynes Education
The University of Glamorgan
Bachelor’s Degree (Chemistry (Hons))
1992-1993
GMIT Galway
Diploma (Diploma in Fine Chemicals and Pharmaceuticals)
1989-1992
Athenry vocational
Declan Hynes Skills
Regulatory Strategy Development
Regulatory Interactions
FDA
ISO 13485
GMP
Regulatory Submissions
Quality System
Regulatory Affairs
Design Control
Medical Devices
Change Control
Regulatory Requirements
CAPA
21 CFR Part 11
Biotechnology
Pharmaceutical Industry
ISO 14971
Validation
U.S. Food and Drug Administration (FDA)
Corrective and Preventive Action (CAPA)
U.S. Title 21 CFR Part 11 Regulation
Good Manufacturing Practice (GMP)
Molecular Biology
Cell Culture
Public Speaking
u.s. Food and Drug Administration Fda
Corrective and Preventive Action Capa
Management
u.s. Food and Drug Administration
Corrective and Preventive Action
Declan Hynes Summary
Declan Hynes, based in Cardiff, GB, is currently a Senior Regulatory Affairs Manager at Ortho Clinical Diagnostics. Declan Hynes brings experience from previous roles at GE Healthcare and Ortho Clinical Diagnostics. Declan Hynes holds a 1992 - 1993 Bachelor’s Degree in Chemistry (Hons) @ The University of Glamorgan. With a robust skill set that includes Regulatory Strategy Development, Regulatory Interactions, FDA, ISO 13485, GMP and more. Declan Hynes has 1 emails on RocketReach.
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