Amit Tripathi Email & Phone Number

Gurugram, Haryana, India

Involved in monitoring the evaluation and regulation of medical devices to ensure their safety and effectiveness by ensuring adherence to regulatory requirements.Supervising the timely reporting of adverse events and product problems associated with medical devices to the US FDA.Ensuring organizational compliance with the FDA's Quality System Regulation, including oversight of quality-related events such as recalls, corrections, and removals.Mentoring and guiding team members in handling regulatory reporting and post-market surveillance processes.Collaborating with cross-functional teams to enhance compliance strategies and address regulatory challenges effectively.

Gurugram, Haryana, India

Involved in evaluating and regulating medical devices to ensure their safety and effectivenessthrough meeting regulatory requirements Responsible for timely reporting of adverse events and product problems associated withmedical devices to the US FDA.Monitoring and analyzing post-market data, including complaints, to identify trends andassess product safety.Ensuring compliance with the FDA's Quality System Regulation, which ensures reporting ofcertain quality-related events, such as recalls, corrections, and removals.

Noida, Uttar Pradesh, India

Handling and supporting Quality Assurance activities for Medical Devices, SaMD for countries like EU, US, Australia, New Zealand and Japan including –  Implementation of Quality Management System (ISO 13485). Gap Analysis and Remediation of Design Review Reports through the development Quality Assurance & New Product Development of Medical Devices  Successfully completed the Risk Assessment and FMEA (ISO 14971)  Assisted in Verification & Validation of Medical Devices Understanding business & compliance requirements of clients Maintained Design History File and Data Master Record of Medical Devices Delivered cross-functional response to stakeholders within time.

Noida, Uttar Pradesh, India

Handled Clinical Studies and Regulatory Affairs for Clinical Studies of Class I and II Medical Devices and Biologics including for countries like EU, India, APAC, US including -  Preparation of Technical Documentation of Medical Devices Submitted Clinical Evaluation Report of Class I and II Medical Devices Completed Clinical Evaluation Plan of Class I and II Medical Devices Provided support to the content management system process. Literature Review and Gap Analysis of Regulatory Dossiers before submission Assisted in Planning & Execution, Process Development of documentation. Handling SOPs, Documenting Work instructions(WIs) Skilled in EU MDR/ MDD 2017 - Medical Devices