
Deepa Moti
Regulatory Affairs Specialist
Deepa Moti is a Regulatory Affairs Specialist with a Biomedical Engineering background and a Master of Science in Regulatory Affairs spanning drugs, biologics, and medical devices from discovery through post-market utilization. That foundation has given her a working command of pharmaceutical and biologics regulatory pathways alongside her device-focused expertise, resulting in a genuinely cross-sector perspective she brings to every engagement. Deepa began her career as a Biomedical Engineer in a hospital setting, working hands-on with medical devices and compliance documentation, before going on to gain experience with Johnson & Johnson MedTech, Medtronic, and a regulatory consulting firm, exposure that has given her a grounded, practical understanding of regulatory affairs, quality systems, and product lifecycle.
Deepa's approach is defined by precision and foresight: rather than simply processing submissions, she builds the regulatory intelligence and strategy that facilitates getting a product into the market.
Deepa's regulatory work spans the complete medical device lifecycle: 510(k) premarket notifications, Q-Submissions, PMA support, and EU MDR technical documentation, with depth in Software as a Medical Device (SaMD) and AI/ML-enabled device regulation. This includes developing regulatory strategy and market intelligence to determine appropriate product classification and the optimal pathway to market, drawing on her work assessing frameworks across the U.S., EU, LATAM, and other international markets, including ISO 13485, MDSAP, and FDA Breakthrough Device pathways. She also developed an FDA cybersecurity submission template aligned with Section 524B of the Federal Food, Drug, and Cosmetic Act, reflecting her attention to the latest and most consequential FDA guidance. Beyond pre-market work, she applies regulatory and international-language requirements to labeling and instructions for use (IFU), ensuring alignment with FDA requirements and EU MDR General Safety and Performance Requirements (GSPR) across diverse regulatory jurisdictions, which is essential work as products move into new and unfamiliar markets. She also supports sustained post-market compliance through deficiency tracking systems, adverse event and vigilance reporting, and technical documentation practices designed to catch recurring compliance risk before it becomes a costly problem.
Deepa's cross-sector depth is reflected in her peer-reviewed publication examining the regulatory landscape of Software as a Medical Device (SaMD) compliance across FDA, EU MDR, and international frameworks. It's emblematic of something she cares about deeply: staying genuinely engaged with the evolving edges of regulatory science, from AI/ML-enabled devices to global harmonization efforts.
Deepa approaches each engagement with precision, discipline, and a firm commitment to guiding clients through complex and evolving regulatory requirements translating technical and legal complexity into clear, defensible pathways to market.


