Srividya Narayanan

Dr Srividya Narayanan is a regulatory affairs and compliance specialist specialising in the intersection of AI, cybersecurity, and digital health regulation. Currently a Regulatory Affairs Researcher at Freyr Solutions and pursuing her Master's in Regulatory Affairs at Northeastern University, she develops AI-powered regulatory screening tools and automated compliance tracking systems for medical device submissions. As founder of Regulatory Navigator, an AI-powered compliance platform serving 50+ countries with expected 95%+ accuracy, she's transforming how the industry approaches Software as a Medical Device (SaMD) regulation and wearable medical device compliance. Dr Narayanan combines her clinical background as a dental surgeon with deep expertise in cybersecurity validation, AI/ML frameworks (ISO 62304, ISO 62366, ISO 60601), and HITRUST/SOC 2 compliance. As Co-founder of Path2RAQA, she mentors international students navigating career transitions into regulatory affairs, proving that unconventional backgrounds drive innovation in emerging regulatory spaces. She is an ambassador for ISPE and AnitaB.org, and she is a global speaker who has also spoken at around 20+ organizations on AI, cybersecurity and wearables regulations.