Sonika Bhatt

Experience

1. Regulatory Affairs Executive

   Auxein Medical

   May 2022 — Present · Sonipat, IN

   Responsible for the GAP analysis in the MDD and MDR in the current devices. Provides guidance on global compliance, such as CE Marking and product registrations. Experience in managing Clinical Evaluations and writing/updating Clinical Evaluation Reports (CERs) for EU MDR compliance. Actively involved in the Technical file preparation of various Class 2 and 3 devices in accordance with MDR. To ensure that a company\'s products comply with the current regulations. Keeping in touch with international legislation, guidelines and customer practices. Formulate regulatory strategy for all appropriate regulatory submissions for domestic and international markets. Coordinate, prepare and review all appropriate dossier and submit them to regulatory authorities in the different countries. Actively monitor the progress of all registration submission. Respond to queries as they arise, and ensure that registration / approval is granted without delay. Advising regulatory aspects of any amendment that would affect the devices.

Education

• Chitkara University

  Master of Pharmacy , Pharmaceutics

  2017 — 2019

• Chitkara University

  Bachelor of Pharmacy (B.Pharm.), Pharmacy

  2013 — 2017