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Ira Dave Location
California, United States
Ira Dave Work
Senior Director, Quality and Regulatory @ (January 2022 - Present)
Senior Director, Quality, Regulatory Compliance and Strategy @ (July 2021 - January 2022)
Senior Director, Quality @ (April 2020 - January 2022)
Senior Director, Quality Assurance @ (February 2017 - March 2020)
Manager, Quality Systems and Compliance @ (April 2012 - January 2015)
Founder, Quality and Regulatory Principal @ Altoviya (April 2003 - December 2012)
Consultant @ (January 2003 - January 2012)
Consultant @ Synvascular (January 2009 - January 2009)
Qs @ (January 2004 - January 2006)
Environmental and Quality Specialist @ (August 2001 - December 2002)
Ira Dave Education
University of South Carolina
Masters (Management)
1999-2001
Sophia College, Univ. Of Mumbai
Masters
1995-1999
Ira Dave Skills
ISO
Auditing
Documentation/ System Development
ISO 13485/ 21 CFR 820/ 21 CFR 211/ ICH
CE marking medical device
Device registrations/ licenses/ 510k
CE marking
GMP
ISO 13485
ISO 14971
Medical Devices
Iso 9000
Quality Assurance
Quality System
Risk Management
Root Cause Analysis
Software Documentation
Validation
FDA
Management
Product Development
Cross-functional Team Leadership
Manufacturing
Corrective and Preventive Action (CAPA)
Biotechnology
Design Control
ISO 9001
Verification and Validation (V&V)
Life Sciences
Regulatory Affairs
Research and Development (R&D)
Quality Management
Leadership
Continuous Improvement
Compliance Management
Ira Dave Summary
Ira Dave, based in California, United States, is currently a Senior Director, Quality and Regulatory at Elixir Medical Corporation. Ira Dave brings experience from previous roles at Bd, Biocardia and Intersect Ent. Ira Dave holds a 1999 - 2001 Masters in Management @ University of South Carolina. With a robust skill set that includes ISO, Auditing, Documentation/ System Development, ISO 13485/ 21 CFR 820/ 21 CFR 211/ ICH, CE marking medical device and more. Ira Dave has 2 emails and 1 mobile phone numbers on RocketReach.
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