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Nirav Desai Location
Boston, MA, US
Nirav Desai Work
2023 -now Senior Vice President of Global Quality, Regulatory and Clinical @
2021 -now Professor- Masters of Science in Regulatory Affairs @
2021 -2023 Global Head of Quality and Regulatory Affairs @
2019 -2021 Director of Quality Systems and Quality Engineering @
2011 -2021 Director Quality Engineering @
2011 -2012 Regulatory Affairs Specialist @
2017 -2021 Quality and Regulatory Advisor @
2010 -2011 Regulatory Affairs @
2010 -2011 Regualtory Affairs- Chemistry Manufacturing and Control Associate @
2011 -2011 Quality Assurance Engineer @
2008 -2009 Manufacturing and Quality Control @
Nirav Desai Education
Mumbai University
Bachelors (Pharmaceutics, Biotechnology, Pharmaceutical Analysis and Biopharmaceutics.)
Northeastern University
Master of Science (M.S.) (Regulatory Affairs)
Nirav Desai Skills
Executive Presentations
Engineering
FDA
GMP
Validation
Quality System
Regulatory Affairs
CAPA
Medical Devices
Pharmaceutical Industry
Regulatory Submissions
Sterilization
Clinical Trials
GCP
R&D
IND
Quality Assurance
GLP
21 CFR Part 11
eCTD
Manufacturing
Biotechnology
PMA
510 K
cGMP
SOP
Auditing
Clinical Trial Management
Quality Systems
Cleaning Validation
Pharmaceuticals
ISO 13485
ANDA
Clinical Research
QSR
Pharmacovigilance
ISO
Compliance
Change Control
ICH-GCP
Quality Auditing
IDE
Technology Transfer
CE marking
Internal Audit
ISO-Quality Systems Auditor
Supplier Quality
Design Control
Minitab
Complaint Investigations
Documentation
IRB
Java
Clinical Trial
Iso Quality Systems
Ich Gcp
Management
Process Improvement
Iso Quality Systems Auditor
Microsoft Word
Nirav Desai Summary
Nirav Desai, based in Boston, MA, US, is currently a Senior Vice President of Global Quality, Regulatory and Clinical at Cynosure, LLC.. Nirav Desai brings experience from previous roles at Northeastern University, Quanta Dialysis Technologies, Fresenius Medical Care North America and NxStage Medical, Inc.. Nirav Desai holds a Bachelors in Pharmaceutics, Biotechnology, Pharmaceutical Analysis and Biopharmaceutics. @ Mumbai University. With a robust skill set that includes Executive Presentations, Engineering, FDA, GMP, Validation and more. Nirav Desai has 2 emails and 4 mobile phone numbers on RocketReach.
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