Marilyn Gatin, Ph.D., RAC, is an Associate Director in the Healthcare and Life Sciences Disputes, Regulatory, Compliance, and Investigations (HLS DRCI) practice, focusing on FDA regulatory matters.
Marilyn is an R&D and regulatory affairs professional with over 21 years of experience in the medical device, combination product, IVD, tissue, and laboratory spaces. Her expertise includes product commercialization, design control/product realization, process mapping, labeling/promo material review, product regulatory assessment, quality systems, risk management, root cause analysis, statistics, and critical process improvements. Marilyn’s practice is focused on delivering robust products, efficient processes, complex system improvements, and careful regulatory oversight to align with techni cal needs and business concerns. She is highly skilled at facilitating internal and external cross-functional interactions to deliver quality results under dynamic conditions. Marilyn has extensively presented at national conferences and published in peer-reviewed journals.