Gayathri has worked for 4+ years in regulatory domain for biologics, medical devices, and clinical study management. She holds a Master of Science in Regulatory Affairs from Northeastern University and Bachelor of Technology in Biotechnology. She has worked across a diverse spectrum of regulations from preparing vaccine dossiers for global markets to leading 510(k) submissions for Class II and III devices. She has a strong track record in FDA submissions, Health Canada MDL applications, and regulatory strategy, and her contributions have been acknowledged in two FDA 510(k) summary pages namely K252161 and K251784.