SAMD SME

As a Software As Medical devices Subject Matter Expert (SME) at Tata Elxsi in Pune, you will play a crucial role in leveraging your experience and knowledge to contribute to the development of medical devices. You will be part of a dynamic team that values innovation and growth. Your responsibilities will include: - Possessing a Bachelor's degree in a relevant field or equivalent experience. - Having 6 to 8 years of experience in a regulated industry, with a preference for FDA and Software as a Medical Device. - Demonstrating a strong understanding of FDA Quality System Regulations, particularly 21 CFR 11 and 21 CFR 820. - Drafting and submitting regulatory filings such as Q-Submission requests, Traditional and Special 510(k) filings, with a focus on Software as Medical Device. - Working with US FDA Class I and II medical devices, with additional exposure to FDA Class III devices and OUS device classification being advantageous. - Engaging with US and OUS Regulatory Authorities through Q-Submission meetings, product Deficiency Response meetings, and regulatory inspections. At Tata Elxsi, you will be part of a culture that values your expertise and offers opportunities for professional growth and development. Join us to be a part of shaping the future of the medical devices industry.,