Srividya Narayanan

Background

About Srividya Narayanan

Seeking Full-Time Regulatory Affairs Opportunities in Medical Devices & MedTech (Spring 2026) where I can contribute to product development, regulatory strategy, and bringing innovative technologies to market faster—and smarter. My journey hasn't been linear—it's been intentional. In 2018, I transformed failure into fuel, securing a government seat for my MDS and graduating as a University Silver Medalist. But standing in the operating room, I realized my impact could extend beyond one patient at a time. I wanted to be at the intersection where clinical insight meets regulatory strategy—where we accelerate how life-changing medical technologies reach patients. That vision led me to Northeastern's MS in Regulatory Affairs program, where theory met reality through job applications, countless rejections, and ultimately, meaningful breakthroughs. What I've built along the way- Regulatory Navigator - An AI-powered compliance platform serving medical device professionals across 50+ countries, reducing regulatory research from hours to minutes - Path2RAQA - Co-founded to help aspiring regulatory professionals break into the industry (because I know how hard that path can be)- Real-World Impact - At Freyr Solutions, I'm shaping regulatory intelligence for SaMD and digital health products, contributing to AI-powered screening tools that enhance submission accuracy 2025 has been a year of amplifying that impact: From Hacking Medicine at MIT to speaking at 20+ international conferences across 3 continents (PDA Europe, DIA, AAPS, ISPE, TOPRA Berlin, ASQ), I've shared insights on AI in regulatory affairs, cybersecurity audits for medical devices, and bridging clinical expertise with compliance strategy. What drives me: Transforming complex regulatory challenges into clear pathways for medical breakthroughs. Every FDA 510(k), every MDR submission, every compliance framework I work with represents patients waiting for innovations that could change their lives. What I bring: Clinical foundation (MDS, Periodontics) meets regulatory expertise (FDA, EU MDR, ISO 13485) Hands-on experience with SaMD, digital health, and AI/ML regulatory frameworks Proven ability to automate compliance workflows and reduce documentation time by 30% Deep understanding of the full product lifecycle—from design controls to post-market surveillance Let's connect: srividyan62@gmail.com Specialties: FDA 510(k)| EU MDR | SaMD | Digital Health | ISO 13485 | Risk Management | Regulatory Strategy | AI in Regulatory Affairs | Medical Device Compliance | Cybersecurity