Parul Chansoria

Parul Chansoria is an accomplished Senior Director of Regulatory and Quality Compliance at Elexes Medical Consulting LLC since June 2015, with a robust portfolio that includes over 20 successful 510(k) submissions, extensive experience with FDA pre-submissions, and multiple Breakthrough Device Designations. With expertise in FDA QSR, ISO 13485 compliance, and medical device development, Parul has led numerous audits, authored Technical Files, and created Clinical Evaluation Reports. Prior roles include positions at Intuitive Surgical, Home Dialysis Plus, and Stryker, where responsibilities spanned regulatory strategy formulation, submission preparation, and compliance assurance. Parul holds a Master's degree in Bioengineering from the University of Illinois Chicago and has furthered professional credentials as a Certified Regulatory & Quality Professional with the Regulatory Affairs Professionals Society since 2011.