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Megha Sinha Location
United States
Megha Sinha Work
Founder and CEO @ (June 2026 - Present)
Member @ (January 2025 - Present)
Managing Partner and CEO @ (March 2023 - Present)
Health Industries Strategy and Transformation | Global Regulatory Consulting Solutions Leader @ (January 2015 - February 2023)
Global Regulatory Affairs, Quality, and Post Market Compliance @ (April 2012 - May 2015)
Head, Global Regulatory Affairs and Manufacturing Quality Assurance @ (January 2011 - January 2012)
Consultant (System and Process) for Neutrogena, a J and J company @ (January 2011 - January 2011)
Associate @ (January 2008 - January 2009)
Project Trainee @ (May 2006 - September 2006)
Megha Sinha Education
University of Southern California
Master of Science (Biomedical Engineering; Regulatory Affairs)
RV College Of Engineering
Bachelor of Engineering (Chemical Engineering)
Megha Sinha Skills
Budgeting
Business Strategy
Standard Operating Procedure (SOP)
FDA GMP
Continuous Improvement
Project Management
Sales
Business Development
Strategic Initiatives
CEOs
FDA
Regulatory Affairs
Medical Devices
ISO 13485
Quality Assurance
21 CFR
Validation
Microsoft Office
CAPA
Matlab
ISO 14971
Regulatory Submissions
Six Sigma
Quality System
ISO 10993
Document Management
C++
21 CFR Part 11
Biomedical Engineering
Clinical Trials
Cross-functional Team Leadership
R&D
GMP
510 K
21 CFR Part 820, 801,803,100, 807, 814
Certificate for Foreign Goverment
SOP Authoring
Management
Leadership
Quality Control
Design Control
Strategy
Manufacturing
Pharmaceutical Industry
Process Improvement
Biotechnology
Training
Product Development
Product Launch
Management Consulting
Megha Sinha Summary
Megha Sinha, based in United States, is currently a Founder and CEO at Kolter AI. Megha Sinha brings experience from previous roles at WBL (Women Business Leaders of the US Health Care Industry Foundation), Kamet Consulting Group, PwC and Stryker. Megha Sinha holds a Master of Science in Biomedical Engineering; Regulatory Affairs @ University of Southern California. With a robust skill set that includes Budgeting, Business Strategy, Standard Operating Procedure (SOP), FDA GMP, Continuous Improvement and more. Megha Sinha has 2 emails and 5 mobile phone numbers on RocketReach.
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