I am a Senior Regulatory Affairs Specialist at Tata Elxsi, where I ensure compliance with medical device regulations, such as MDR and, for various clients in the healthcare industry. I have over 7.6 years of experience in quality assurance, Regulatory Affairs, working with leading companies like L&T Technology Services Limited, Biorad Medisys Pvt Ltd, and Escon Gensets Pvt Ltd. I have developed and implemented quality management systems, conducted audits and inspections, and prepared and reviewed regulatory submissions and documentation. I have also contributed to multiple projects involving product development, testing, validation, and certification. I am proficient in multiple skills, such as Medical Device Regulation (MDR), 510(k), ISO 14971, ISO 13485, and CAPA. I am passionate about enhancing the safety and performance of medical devices and improving the quality of life for patients.