Tanvi Chaudhary
Regulatory Affairs Specialist, Medical devices
- Role
- Regulatory Affairs Specialist-product Development at Iridex
- Location
- Sunnyvale, CA, US
- LinkedIn followers
- 500 followers
About Tanvi Chaudhary
Passionate Regulatory Affairs professional with 4.5 years of experience in Regulatory Affairs and Safety Reporting. • Well-versed with medical device regulatory requirements (FDA, EU, and various OUS Market), combination product regulatory requirements (FDA, EU, Australia, and Canada), • Prior experience in Drug Regulatory Affairs and post-market safety reporting • Adept in team leadership, effective team collaboration and communication, and project prioritization
Experience
Regulatory Affairs Specialist-product Development
Aug 2023 — Present · Mountain View, CA, US
Preparation of Class IIa and IIb technical documentation per EU MDR requirements • Preparation and submission of Annual Laser Reports for Class II products to the US FDA • Preparation of international product submissions per OUS requirements
Education
St Stephens School, Chandigarh
Higher Education, ICSE
1994 — 2006
National Law School of India University
Post Graduate Diploma, Intellectual Property Rights Law, 5.00/7.00
2013 — 2015
St. Cloud State University
Master's degree, Regulatory Affairs and Services, 4.0
2020 — 2022
Jaypee University of Information Technology
Bachelor's degree, Pharmacy, 3.51
2008 — 2012
Jaypee University of Information Technology
Master's degree, Pharmaceutics, 3.54
2012 — 2014
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