Required Attributes :Master’s degree/Ph.D in Biomedical Engineering, Life Sciences, Biotechnology, or a related field. 6-10 years of experience in regulatory affairs and quality management within the IVD or medical device industry. In-depth knowledge of global regulatory standards and quality management systems, including ISO 13485, ISO 14971, EU IVDR, US FDA 21 CFR 820, and CDSCO.Proven experience in leading regulatory submissions and successful product