Vivek T.

Vivek T. is an experienced professional in the field of regulatory affairs and biomedical engineering, holding a Bachelor's degree from the University of Mumbai and a Master's degree from the University of Southern California. Career highlights include roles as a Clinical-Regulatory Affairs Intern at Alfred E Mann Foundation, a Biomedical Engineering Intern at Lilavati Hospital and Research Centre, and various positions in regulatory affairs at prominent companies such as Roche, where work focused on AI-ML SaMD for oncology and ophthalmology drug development, and Idoven as Vice President of Regulatory Affairs & Quality Assurance in cardiovascular applications. Currently serving as Medical Device Compliance at Meta and recently worked as a Sr. Digital Health Consultant at Biologics Consulting, Vivek has extensive experience across multiple regulatory frameworks including US FDA, EU MDR, and global markets for interventional cardiovascular devices. Previous positions also include consulting roles at Caldera Medical and a Global Regulatory Affairs Manager position at Cardinal Health, emphasizing a strong background in compliance and quality assurance.