Discover Xtalks Featured Community Member Srividya Narayanan, MDS, MS, SaMD Regulatory Researcher at Freyr Solutions and Graduate Student at Northeastern University, who is transforming how AI and regulatory science intersect. Read how she’s shaping the future of intelligent regulation and global digital health compliance through innovation and advocacy.
What Are Your Proudest Life Science Achievements?
My proudest achievement is the complete transformation of my career trajectory through relentless determination. After facing over 1,000 rejections for co-op and internship positions in 2024, I channeled that adversity into action by founding Regulatory Navigator, an AI-powered compliance platform now serving medical device and biopharma professionals across 50 countries. This platform reduces regulatory research time from hours to minutes with expected 95%+ accuracy.
Equally significant is becoming an internationally recognized voice in regulatory affairs, delivering presentations at 10+ major conferences in 2025 alone — from PDA Europe in Spain to TOPRA Berlin Symposium — covering critical topics like AI-powered virtual care regulation and cybersecurity audits for medical devices. My academic journey from ranking 7000th in NEET PG 2017 to achieving AIR 195 in 2018, earning my MDS as University Silver Medalist, and now maintaining a 3.8 GPA in my Master’s in Regulatory Affairs demonstrates that persistence and strategic growth can overcome any obstacle.
Most recently, winning MIT Hacking Medicine with Synapsense, our AI-driven assistive technology, validated my ability to bridge clinical expertise with regulatory innovation to create real-world solutions that advance patient care.
I was recently featured in Times Square as one of the “Top 100 Mentors and Creators” by Topmate, which has been an incredibly humbling milestone and a continuation of my mission to make regulatory science more accessible and inspiring for emerging professionals.
What Are Your Day-to-Day Job Highlights?
At Freyr Solutions, my days are energized by transforming complex regulatory intelligence into accessible content that empowers the medtech community. I particularly enjoy diving deep into Software as Medical Device (SaMD) regulations and emerging digital health frameworks, then distilling these intricate requirements into clear blog posts, whitepapers and LinkedIn content that practitioners can immediately apply.
The most rewarding moments come when collaborating with cross-functional teams to track industry trends and translate regulatory updates into strategic insights. Contributing to AI-powered regulatory screening tools allows me to combine my clinical background with technical innovation — seeing how automation can enhance accuracy in medical device submissions while maintaining the rigorous standards our industry demands.
What truly excites me is the exposure to RIMS/Freya fusion activities, where I’m learning how sophisticated regulatory information management systems can revolutionize compliance tracking. Every day presents opportunities to support global regulatory strategies while building my expertise in how leading organizations navigate the evolving landscape of FDA pathways, EU MDR requirements and international harmonization efforts.
What Are Your Favorite Life Science Innovations?
I’m captivated by the convergence of artificial intelligence and regulatory science — particularly how AI is transforming post-market surveillance and real-world evidence generation. SaMD represents a paradigm shift in how we approach patient care, and watching regulatory frameworks evolve to accommodate AI/ML-enabled medical devices while maintaining safety standards is incredibly inspiring.
The innovations in digital health platforms that seamlessly integrate clinical workflows with regulatory compliance fascinate me. Technologies that enable continuous monitoring through wearables, coupled with robust cybersecurity frameworks and adaptive algorithms, are revolutionizing personalized medicine. I’m particularly excited about how the International Medical Device Regulators Forum (IMDRF) harmonization efforts are creating pathways for these innovations to reach global markets more efficiently.
From my clinical background, I deeply appreciate regenerative medicine advances and minimally invasive surgical technologies that I witnessed firsthand in periodontics. But what truly captivates me now is the regulatory innovation itself — tools like real-time adverse event reporting systems, automated compliance screening and AI-powered pathway wizards that are democratizing access to regulatory expertise and accelerating how life-changing therapies reach patients.
What Is Your Vision for the Future of the Industry?
My vision centers on intelligent regulation that accelerates innovation without compromising safety. The future belongs to adaptive regulatory frameworks that leverage AI and real-world data to make evidence-based decisions in near real-time, reducing the traditional 18-month review cycles while maintaining rigorous safety standards.
I envision a globally harmonized regulatory ecosystem where IMDRF principles are universally adopted, eliminating redundant submissions and enabling breakthrough therapies to reach patients worldwide simultaneously. AI-powered compliance platforms will become standard practice, providing instant regulatory intelligence, automated pathway recommendations and predictive risk assessments that guide development from concept through post-market surveillance.
The integration of cybersecurity, data integrity and algorithmic transparency will be fundamental and not afterthoughts in medical device development. As virtual care and telemedicine 2.0 become mainstream, we’ll need regulatory frameworks that can evaluate continuous software updates and adaptive algorithms while ensuring patient safety.
Most importantly, I see a future where the regulatory profession is accessible to diverse talent through platforms like Path2RAQA, where clinical insights directly inform regulatory strategy, and where every stakeholder, from startups to global manufacturers, can navigate compliance efficiently. This democratization of regulatory knowledge will ultimately accelerate medical breakthroughs and improve global health equity.
The future isn’t about choosing between innovation and safety — it’s about creating intelligent systems that enhance both simultaneously.
Apply Yourself or Nominate a Peer
Do you know someone doing incredible work in the life sciences? Or perhaps you’re proud of your own journey and want to inspire others? We’d love to hear from you.
You can apply to be an Xtalks Featured Community Member or nominate a colleague through our simple online form. It takes just a few minutes, and it could open doors to new conversations, partnerships and recognition across the industry.
Let’s celebrate the people driving life sciences forward, one story at a time.
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