Background
Ms. Parul is a Biomedical Engineer by profession with more than 10 years of medical device and IVD experience. Parul is a Certified Quality Auditor (CQA) by American Society for Quality (ASQ), RAC certified by RAPS, a trusted thought leader and a decision maker for regulatory strategy, product testing, design controls, risk management, supplier control, quality assurance, regulatory compliance, clinical evaluations, and post-market controls. With a Masters’s in Bioengineering from UIC, Chicago, she is passionate for medical device and IVD development and has served as the Regulatory and Quality Director for several medical device companies across the world.
Chronology
2014 – Present
Founder and CEO at Elexes (WY, CA, USA; Bangalore, India) Acting Quality and Regulatory Director of medical device companies (Globally)
2014
Senior Regulatory Specialist at Intuitive Surgical (Sunnyvale, CA, USA)
2013 – 2014
Senior Regulatory Specialist at Outset Medical (Sunnyvale, CA, USA)
2012 – 2013
Regulatory Affairs at Stryker Corporation (San Jose, CA, USA)
2009 – Present
Regulatory Affairs Professionals Society Member (RAPS) (Palo Alto, CA, USA) Regulatory Consultant and Trainer (several medical device and IVD companies)
2007 – 2009
Researcher at the Department of Cardiology, UIC (Chicago, Illinois)
Skills
- – European CE Marking
- – Regulatory strategy
- – Clinical Evaluation Reports (CERs)
- – DHF, risk management, and testing
- – International regulatory requirements
- – ISO 13485, MDSAP, and FDA QSR compliance
Contact Info
Email: parul@elexes.com Number: +1-408-475-809
