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.

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.

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.

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.

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.

Meet the Instructor

I am Nivedha Subramanian, a biomedical engineer turned regulatory affairs specialist, and my strength is translating complex regulatory requirements into practical, usable knowledge. I have worked across FDA, Health Canada, and EU MDR pathways, building technical files, managing submissions, supporting audits, and navigating real compliance challenges. I break down regulations the way I wish someone did when I started!

I am RCC MDR certified, an ISO 13485 Lead Auditor, Lean Six Sigma trained, and I contribute to the ISO/TC 210 and CSA standards development committees, keeping me closely connected to evolving regulatory expectations. I have also completed formal training and facilitation programs, ensuring every session is structured, well paced, and easy to absorb.

Today, more than 85 regulatory professionals have trusted this journey for learning that is practical, engaging, and built to last - I’d love for you to be next!

NIVEDHA SUBRAMANIAN

MS, RCC - MDR