About Us
Empowering Regulatory Professionals — One Lesson at a Time
RegStalk is more than just a training platform — it’s a movement to make regulatory education practical, affordable, and genuinely empowering for professionals in the medical device space.
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We specialize in simplifying complex regulatory topics through bite-sized, real-world-focused sessions that fit your schedule and your budget. Whether you're new to RA/QA or looking to grow into more advanced roles, RegStalk is designed to support your journey with clarity, confidence, and community.
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Mission - To make structured and high-impact regulatory training accessible to anyone, anywhere.
Vision - To become the global standard for structured regulatory learning that empowers professionals to grow with confidence, apply with clarity, and advance with purpose.
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Our Story
RegStalk was born from a simple yet powerful realization: most regulatory training is overwhelming, expensive, and disconnected from the realities of day-to-day work. After years of navigating regulatory affairs across global markets, our founder, Nivedha Subramanian, recognized that the gap lies not in the lack of information, but in how it is delivered. Random, scattered learning leads to confusion and forgotten knowledge, making it difficult for professionals to build lasting expertise.
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Determined to address this challenge, what began as a small idea quickly grew into a thriving platform—a space where professionals can learn in a clear, step-by-step way that fits their pace, gain practical insights, and connect without barriers. The platform is designed to build confidence and competence over time, without overwhelming or alienating learners.
Meet the Instructor
Hey there! I'm Nivedha Subramanian, a biomedical engineer turned regulatory affairs specialist with 6+ years of global experience in the medical device industry. I’m RCC-MDR certified, an ISO 13485:2016 Lead Auditor, Lean Six Sigma trained, and hold a Master’s in Regulatory Affairs. I’ve worked extensively on FDA 510(k)s, Health Canada MDLs, EU MDR documentation, and global QMS audits—bringing a blend of regulatory strategy and hands-on execution.
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My strength is turning complex regulatory concepts into clear, practical learning you can actually use. Over 70 professionals have already joined the journey—I’d love for you to be next!
NIVEDHA SUBRAMANIAN
MS, RCC - MDR