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

  1. Regulatory Affairs Specialist-product Development

    Iridex

    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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Tanvi Chaudhary — Regulatory Affairs Specialist-product Development at Iridex in Sunnyvale, CA, US | Unifers