Ankit J Shah

Senior Director, Quality @Guardant Health

San Francisco, CA, US
EMAILS
a•••••@guardanthealth.com
MOBILE NUMBERS
+12•••••••83

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WORK HISTORY

Feb 2021 — Present

Senior Director, Quality @Guardant Health

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EDUCATION

2007 — 2008

University of Southern California

M.S., Biomedical Engineering

2016 — 2018

Stanford University Graduate School of Business

LEAD Executive Education Program

SKILLS

U.s. Title 21 Cfr Part 11 RegulationMedical DevicesCapaQuality AuditingProject ManagementRegulatory AffairsDesign ControlCe MarkingInternal AuditGmp21 Cfr Part 11FdaMedical Device DirectiveValidationQuality SystemCorrective and Preventive Action (Capa)Iso 14971Biomedical EngineeringIso 13485

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.

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