Executive Vice President, Regulatory and Quality @ (January 2019 - January 2019)
Vice President, Head of Medical Care Global Regulatory Affairs @ (January 2013 - January 2018)
Adjunct Professor @ (January 2016 - January 2017)
Sr. Vice President, Regulatory, Quality, Clinical and Medical Affairs @ (January 2011 - January 2012)
Sr. Director, Regulatory, Quality, Clinical and Standards @ (January 2007 - January 2011)
Director, Regulatory Affairs, Compliance Engineering and Technical Communications @ (January 2005 - January 2007)
Department Head, Regulatory, Quality, Clinical Relations and Business Development @ (January 2001 - January 2005)
Regulatory and Quality and Business Development and Research and Development @ (January 1994 - January 2001)
Research Scientist @ (January 1992 - January 1993)
Donna Haire Education
Cleveland State University
M.S. (Biology)
The University of Akron
B.S. (Biology)
Donna Haire Skills
FDA
Medical Devices
Design Control
ISO 13485
CAPA
V&V
Quality System
Biotechnology
Regulatory Affairs
Validation
GMP
Quality Assurance
Cross-functional Team Leadership
Product Development
R&D
ISO 14971
SPC
Healthcare
ISO
Clinical Affairs
Medical Affairs
JPAL
MDD
International Regulations
Business Excellence
TQM
DFSS
Sustainability
Benchmarking
Balanced Scorecard
Key Performance Indicators
Instrumentation
Clinical Research
Cross Functional Team Leadership
CE marking
21 CFR Part 11
Commercialization
Donna Haire Summary
Donna Haire, based in Brecksville, OH, US, is currently a Chief Operating Officer at FluoGuide A/S (Nasdaq: FLUO). Donna Haire brings experience from previous roles at FluoGuide A/S, BioPorto A/S, Sedana Medical, AB and The Eriah Group. Donna Haire holds a M.S. in Biology @ Cleveland State University. With a robust skill set that includes FDA, Medical Devices, Design Control, ISO 13485, CAPA and more. Donna Haire has 3 emails and 1 mobile phone numbers on RocketReach.
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