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Windi Hary Location
Los Gatos, CA, US
Windi Hary Work
Head of Quality and Regulatory @ (August 2023 - Present)
Regulatory Advisor @ (May 2021 - Present)
Regulatory Advisor @ (May 2021 - Present)
Regulatory Partner @ (March 2023 - August 2023)
Chief Regulatory and Quality Officer @ (February 2021 - January 2023)
Senior Vice President Global Clinical, Quality and Regulatory Affairs @ (February 2016 - February 2021)
Senior Vice President Global Clinical, Quality and Regulatory Affairs @ (February 2016 - January 2021)
Quality & Regulatory Manager @ (July 2005 - May 2010)
Windi Hary Education
Stanford University
Master Of Arts (European Studies, Russian)
2000
Vanderbilt University
Bachelor Of Arts (European Studies, Russian)
1998
Windi Hary Skills
13485 Lead Auditor
21 CFR
21 CFR Part 11
Analytical Skills
Business Process Improvement
CAPA
CE marking
Change Control
Continuous Improvement
Corrective and Preventive Action (CAPA)
Cross-functional Team Leadership
DICOM
Design Control
Digital Health
FDA
GMP
Good Clinical Practice (GCP)
Growing Teams
ISO 13485
ISO 14971
Internal Audits
Interpersonal Communication
MDSAP
Medical Devices
Medical Imaging
Medical device software
PACS
Part 820
Process Improvement
Product Development
Product Launch
Quality Assurance
Quality Assurance Management
Quality Auditing
Quality Risk Management
Quality System
Quality System Implementation
Quality System Management
Regulatory Affairs
Regulatory Strategy
Risk Management
SaMD
Software Quality Assurance
Strategic Initiatives
Strategy
Succession Planning
U.S. Food and Drug Administration (FDA)
V&V
Validation
Cross Functional Team Leadership
u.s. Food and Drug Administration Fda
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 13485 Lead Auditor, 21 CFR, 21 CFR Part 11, Analytical Skills, Business Process Improvement and more. Windi Hary has 2 emails and 2 mobile phone numbers on RocketReach.
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