Ankit J Shah
Senior Director | Quality Assurance | Regulatory Compliance | Quality Governance | Regulatory Affairs | Stanford LEAD |
- Role
- Senior Director, Quality at Guardant Health
- Location
- San Francisco, CA, US
- LinkedIn followers
- 500 followers
About Ankit J Shah
Innovative, solution oriented, collaborative, hands-on servant leader with proven success in quality systems management, continual improvement, risk management and practical regulatory compliance.16+ years of progressive expertise in designing, effectively maintaining, evaluating and defending quality management systems, in addition to developing & managing regulatory strategies with innate ability to navigate ambiguity through critical thinking and situational leadership.16+ years of extensive experience in Medical Devices & Medical Technology, specifically with precision oncology, combination products, implantables, radiation oncology, SaMD, clinical laboratories and managing relationships with global regulatory agencies.
Experience
Senior Director, Quality
Feb 2021 — Present
Education
University of Southern California
M.S., Biomedical Engineering
2007 — 2008
Stanford University Graduate School of Business
LEAD Executive Education Program
2016 — 2018
Skills
- U.s. Title 21 Cfr Part 11 Regulation
- Medical Devices
- Capa
- Quality Auditing
- Project Management
- Regulatory Affairs
- Design Control
- Ce Marking
- Internal Audit
- Gmp
- 21 Cfr Part 11
- Fda
- Medical Device Directive
- Validation
- Quality System
- Corrective and Preventive Action (Capa)
- Iso 14971
- Biomedical Engineering
- Iso 13485
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