Regulatory Consultant

Erika Ross Ellison is a regulatory and clinical strategy expert with deep experience guiding novel neurotechnologies from concept to market. She served as Vice President of Global Clinical, Regulatory, and Quality at ONWARD Medical, where she led spinal cord stimulation therapies through FDA market authorization (2024), IDE study approval (2025), and CE Mark (2025). Earlier, she advanced neuromodulation therapies for Parkinson’s disease and chronic pain at Abbott and built regulatory and clinical foundations for Cala Health’s digital neuromodulation platform.

Erika is President of the IEEE Engineering in Medicine & Biology Society (EMBS), representing 14,000 bioengineers worldwide, and Founder of Ross Ellison Consulting, where she advises early-stage companies and serves as a fractional Chief Clinical & Regulatory Officer. She began her career at Mayo Clinic developing neurostimulation technologies and leading DARPA-funded clinical research. She holds a Ph.D. in Neuroscience from Mayo Clinic, focused on neural engineering and deep brain stimulation.