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Windi Hary Location
Los Gatos, CA, US
Windi Hary Work
2023 -now Head of Quality and Regulatory @
2021 -now Regulatory Advisor @
2021 -now Regulatory Advisor @
2023 -2023 Regulatory Partner @
2021 -2023 Chief Regulatory and Quality Officer @
2016 -2021 Senior Vice President Global Clinical, Quality and Regulatory Affairs @
2016 -2021 Senior Vice President Global Clinical, Quality and Regulatory Affairs @
2005 -2010 Quality & Regulatory Manager @
Windi Hary Education
Stanford University
Master Of Arts (European Studies, Russian)
2000
Vanderbilt University
Bachelor Of Arts (European Studies, Russian)
1998
Windi Hary Skills
Cross Functional Team Leadership
Quality System
Design Control
21 CFR
21 CFR Part 11
Quality Auditing
Product Development
ISO 14971
Medical Imaging
V&V
Business Process Improvement
Regulatory Affairs
GMP
u.s. Food and Drug Administration Fda
Validation
CE marking
Software Quality Assurance
Change Control
Process Improvement
Medical Devices
FDA
DICOM
CAPA
ISO 13485
Quality Assurance
Product Launch
PACS
Corrective and Preventive Action Capa
Corrective and Preventive Action
u.s. Food and Drug Administration
Windi Hary Summary
Windi Hary, based in Los Gatos, CA, US, is currently a Head of Quality and Regulatory at Elucid. Windi Hary brings experience from previous roles at Mass General Brigham, CRO, SimBioSys, Inc., SoftwareCPR and Heartflow, Inc. Windi Hary holds a Master Of Arts in European Studies, Russian @ Stanford University. With a robust skill set that includes Cross Functional Team Leadership, Quality System, Design Control, 21 CFR, 21 CFR Part 11 and more. Windi Hary has 2 emails and 2 mobile phone numbers on RocketReach.
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