About Natalia
Natalia Remmel is a seasoned Regulatory Affairs and Quality professional with extensive experience across the medical device, diagnostics, and pharmaceutical industries. Her expertise spans new product development, post-market compliance, and quality management systems, with particular interests in digital health technologies, AI/ML applications, and Software as a Medical Device (SaMD).
With a strong scientific and technical foundation, Natalia combines deep regulatory knowledge with leadership and project management capabilities to deliver strategic, business-aligned solutions in complex global regulatory environments. She has successfully partnered with cross-functional teams to translate evolving regulatory requirements into scalable and sustainable compliance strategies.
Previously, Natalia held leadership roles at respected organizations where she spearheaded regulatory strategies for innovative and emerging technologies. Her work has included direct engagement with global health authorities, leadership of cross-functional initiatives, and presentations at industry forums.
Natalia has led and supported EU MDR and IVDR transitions, regulatory submissions, supplier programs, and post-market surveillance activities. She is experienced in guiding organizations through regulatory change while maintaining operational efficiency and compliance.
She is a certified Lead Auditor with extensive experience conducting internal and supplier audits, supporting certification readiness, and driving continuous improvement initiatives across regulated organizations.
Natalia Remmel holds a Ph.D. in Biological Sciences (Biophysics) and an M.Sc. in Regulatory Science from Johns Hopkins University.
Outside of her professional work, Natalia enjoys cooking and gardening, attending field hockey games at her child’s sports school, and spending time with her four-year-old corgi. She lives in Hockessin, Delaware.