2012 -2012 Regulatory Affairs Intern @ Regulatory Doctor
2012 -2012 Regulatory Affairs and Quality Intern @ AblaCor Medical Corporation
2007 -2007 Associate Industrial Trainee @
Umesh S Education
Goldey-Beacom College
Master of Business Administration (M.B.A.) (Healthcare Administration)
2014-2016
Northeastern University
Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices (Regulatory Affairs)
2011-2013
Dr. A.P.J. Abdul Kalam Technical University
Bachelor of Pharmacy (B.Pharm.) (Pharmaceutical Sciences)
2004-2008
Kendriya Vidyalaya
High School (Science stream)
2002-2004
Umesh S Skills
FDA
EU Technical File
Regulatory Affairs
Medical Devices
Regulatory Submissions
CAPA
Pharmaceutical Industry
Quality System
Pharmacovigilance
Validation
Clinical Trials
ISO 13485
Regulatory Requirements
PowerPoint
Sop
Biotechnology
Quality Auditing
V&V
Market Research
ANDA
ISO 14971
Risk Analysis
Design Control
Regulatory Documentation
Strategy
FMEA
PMA
CTMS
Drug Delivery
21 CFR Part 11
Clinical Development
Medical Writing
Clinical Data Management
Biologics
510K Submissions
21 CFR 820
Risk Management
European Union
Umesh S Summary
Umesh S, based in Philadelphia, PA, US, is currently a Lead Auditor at TÜV SÜD. Umesh S brings experience from previous roles at Philips, Source Production & Equipment Company, Inc. [SPEC], Wipro Limited and The Himalaya Drug Company. Umesh S holds a 2014 - 2016 Master of Business Administration (M.B.A.) in Healthcare Administration @ Goldey-Beacom College. With a robust skill set that includes FDA, EU Technical File, Regulatory Affairs, Medical Devices, Regulatory Submissions and more. Umesh S has 2 emails on RocketReach.
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