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Nivedha Subramanian, MS, RCC-MDR

Regulatory Affairs Associate
SCIEX, Canada

Nivedha Subramanian, RCC-MDR, holds a Master’s degree in Regulatory Affairs and works as a Regulatory Affairs Associate at SCIEX, Canada. She has over 6 years of experience in the medical device industry, with expertise in global regulatory submissions, post-market surveillance—including complaint handling, adverse event reporting, PSURs, and summary reports—and Quality Management Systems. She is also a certified lead auditor for ISO 13485:2016.

In addition to her industry role, Nivedha is the founder of REGSTALK, a regulatory training platform through which she has supported over 70 regulatory professionals. The platform focuses on simplifying complex regulatory topics and promoting community-based, practical learning that bridges real-world practice with structured knowledge.

Nivedha is actively involved in standards organizations. She serves on the ISO/TC 210 technical committee through the Standards Council of Canada (SCC) and contributes to the Canadian Standards Association Z289 Technical Committee. She has also maintained a long-standing relationship with RAPS, currently serving as an active member of the RAPS Membership Committee, contributing as a question writer for the RCC-IVDR exam at its 2023 launch, and having her work selected as the winning poster at the RAPS Euro Convergence 2023 in Amsterdam, The Netherlands.

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