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Ira Dave Location
California, United States
Ira Dave Work
2022 -now Senior Director, Quality and Regulatory @
2021 -2022 Senior Director, Quality, Regulatory Compliance and Strategy @
2020 -2022 Senior Director, Quality @
2017 -2020 Senior Director, Quality Assurance @
2012 -2015 Manager, Quality Systems and Compliance @
2003 -2012 Founder, Quality and Regulatory Principal @ Altoviya
2003 -2012 Consultant @
2009 -2009 Consultant @ Synvascular
2004 -2006 Qs @
2001 -2002 Environmental and Quality Specialist @
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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