Eriko Yoshimaru | Washington, D.C. | Hogan Lovells

Eriko Yoshimaru

Senior Director of Regulatory Sciences Global Regulatory


Eriko Yoshimaru
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Eriko Yoshimaru leverages her technical background as an engineer, her experience as a former U.S. Food and Drug Administration (FDA) reviewer and a regulatory affairs professional within the medical device industry to assist and advise clients on complex medical device matters. Eriko places a particular focus on digital health, software as a medical device (SaMD) and artificial intelligence/machine learning (AI/ML) technologies, and helps clients develop regulatory strategies and regulatory submissions to bring novel technologies to the market. 

Eriko obtained her doctorate in biomedical engineering from the University of Arizona with a focus in medical imaging and radiology. In her post-doctoral positions, she combined her technical and project management skills to help transition preclinical research into clinical studies. 

Eriko spent nearly four years at the FDA serving as a biomedical engineer and medical device reviewer at the Center for Devices and Radiological Health (CDRH). At the Agency, Eriko served as lead and consulting reviewer, and was involved in FDA internal working groups and technical standard organizations. 

Her involvement with FDA submissions across multiple centers, offices, and divisions, as well as her experience with a wide range of FDA submission types within CDRH, brings valuable insight into how to address and navigate regulatory challenges.

Eriko further developed her practical, real-world experience during the time she spent at one of the world’s largest technology companies, as part of the U.S. regulatory team at the company’s health care vertical.


  • Ph.D., University of Arizona, 2013
  • B.S., Western New England University, 2008