Nikita Garg

About Nikita Garg

I am Nikita Garg, and I have been working in the Regulatory Affairs and Quality Assurance…

Experience

1. Regulatory Affairs Complaint Handling -post Market Surveillance

   Genpact

   Dec 2023 — Present · Gurugram, IN

   Proficient in establishing & maintaining documentations for Quality Management System requirements ISO-13485, ISO-9001, cGMP. Ensure compliance with Indian MDR 2017, CDSCO, ISO 13485:2016. Prepare and maintain Plant Master Files, Device Master Records, and Risk Management Files. Submit regulatory applications through the Sugam Portal, and act as liaison for audits by FDA.Conduct internal audits, CAPA, post-market surveillance, and ensure compliance with cGMP.Preparation of document for post approval change with respect to import license approval as per Schedule IV.Coordinate with CDSCO (DCGI) for registration via Sugam Portal and ensure compliance with regulatory requirements. Preparation of DMF as per Annexure-I of MDR-2017.Ensure timely submission of Medical Device Reports (MDRs) to relevant authorities.To prepare Device Master File for Imports according to provide license in India for sale & distribution purpose according to Appendix II, Fourth schedule, 2017 MDR. Knowledge of labelling and packaging requirements specific to the Indian market. Managed post-market surveillance (PMS) activities as per the PMS plan. Prepare detailed MDRs for submission, ensuring accuracy and adherence to regulatory requirements. Reviewing e-MDRs for assessing accuracy and quality of the records to meet customer expectations. Prepare and submit the MedWatch-3500A Report, MIR Report, HC Report, and IRIS Reports- Initial, Follow-up and Final to the FDA, EU, Health Canada, and TGA; accordingly, in compliance with regulations, guidelines, and the required timeframe. Experienced in Triage process to differentiate between Reportable and non-reportable complaints and determine the reportability decision of serious and non-serious events in accordance with the severity level. Knowledgeable on IMDRF coding conventions for various codes (Health Effect: Clinical Code, Health Effect: Impact Code, Medical Device Problem Code, Investigation Results etc.)

Education

• Jaipur National University, Jaipur

  MSc Biotechnology

  2014 — 2016

• Jamia Hamdard

  Diploma

  2022 — 2023

• Shobhit University,Meerut

  BSc

  2011 — 2014

Skills

• Plant Tissue Culture
• Science
• Sds-Page
• Bioprocess
• Cell Culture
• Biotechnology
• Environmental Biotechnology
• Polymerase Chain Reaction (Pcr)
• Immunology
• Animal Cell Science
• Molecular Biology
• Life Sciences
• Gel Electrophoresis
• Cell Biology