Gayathri has worked for 4+ years in regulatory domain for biologics, medical devices, and clinical domains. She holds a Master of Science in Regulatory Affairs from Northeastern University and Bachelor of Technology in Biotechnology. She began her career at Bharat Biotech, preparing WHO prequalification vaccine dossiers for 15+ global markets, before joining Signant Health, where she managed digital patient-data (eCOA) tools for 10+ clinical trials across the US, UK and Europe. Currently, she partners with early-stage medtech startups to build regulatory strategies and navigate FDA, Health Canada and EU MDR submissions, with work spanning 10+ devices across dental, orthopedic and imaging areas.