SAMD SME

As a Software As Medical Devices Subject Matter Expert at Tata Elxsi, you will play a crucial role in leveraging your expertise to contribute to the development of cutting-edge medical devices. With 6 to 10 years of experience in the field, you will bring a unique perspective and skill set to the team. Your responsibilities will include ensuring compliance with FDA Quality System Regulations, with a strong emphasis on 21 CFR 11 and 21 CFR 820. Your in-depth knowledge of regulatory filings, such as Q-Submission requests and Traditional and Special 510(k) filings, will be instrumental in navigating the complex regulatory landscape. Having worked extensively in a regulated industry, particularly with FDA Class I and II medical devices, you will be well-versed in interacting with both US and OUS Regulatory Authorities. Your experience in conducting Q-Submission meetings, product Deficiency Response meetings, and regulatory inspections will be invaluable in ensuring successful outcomes. A Bachelor's degree in a relevant field or equivalent experience is required for this role. Additional experience with FDA Class III devices and OUS device classification would be a definite advantage. At Tata Elxsi, we value your expertise and provide an environment where you can thrive and make a meaningful impact. Join us in shaping the future of healthcare technology and unlock a world of possibilities at Tata Elxsi.,