Performance driven, problem solver and team player with 10+ years of experience in dealing with Indian FDA, CE certification and other regulatory requirements.Summary of my work is as mentioned below:• Prepare, review and update Technical Master File for CE submission in European Union.• Prepare, review and update Device Master File for Medical device and IVDs for submission in Indian FDA as per Medical Device Rules 2017.• Prepare, review and update Design History File.• Prepare, review and submit the Technical Dossier for various types of applications i.e. Wholesale license, Test license, Manufacturing license, Import license, Registration certificate, Clinical trial etc. as per time line on online portal "SUGAM".• Obtain quality certificates like Production Capacity / Market Standing / Performance / Non-Conviction etc. for taking part in various tenders.• Obtain certificate like Free Sale certificate and Neutral code approval for export purpose.• Maintain and ensure document control systems and its adherence to applicable standards i.e. ISO 13485.• Co-ordinate during audits from Notified bodies as well as CDSCO / FDA related to product and facility.• Co-ordinate with Development, Production, QA / QC department for documentation required for filings of response to audit's non compliance.• Liaison with Local (Valsad), State (Gujarat) as well as Central FDA (Delhi & Ahmadabad) for Technical discussion regarding product permission of medical devices as well as IVDs.• Timely updates about any routine changes and update in Site Master File, Technical Master File, Design History File etc.• Communicate and coordinate with regulatory personnel of different companies abroad for compilation of various documentations required for registration of their product meant to be imported in India.• Prepare Risk Management report as per ISO 14971, Essential Safety Requirement and compile Clinical Evaluation Report etc. as per requirements by coordinating with Development, Production & Quality Control departments and performing literature reviews.• Co-ordinate with various departments for configuration of online Quality Management System i.e. Matrix QMS system.• Vigilant for any regulatory changes occurring and their effect to the business.
Listed skills include Ccna, C, Embedded Systems, C++, and 8 others.
