Eriko Nakatani, PH.D.

Eriko Nakatani has more than 10 years of experience in regulatory strategy development, PMDA consultation, regulatory submission and clinical strategy, and post-approval regulatory activities (including regulatory review of marketing materials and change control). As a senior specialist at MCRA Japan, Nakatani has led the regulatory submissions of many Class III and Class IV medical devices with a focus in orthopedics. Her successful projects include hip and knee implants with novel materials and general surgery products including absorbable surgical materials and robotic surgical systems.  

After completing her doctoral degree in engineering at Keio University, Eriko Nakatani joined a medical device manufacturer and was assigned to the regulatory affairs department. While there, she gained experience with PMDA consultations, regulatory submissions and Q&A centered on orthopedic implants and surgical devices. Eriko was stationed in the U.S. for one year, during which time she managed reporting of manufacturing changes and multiple product changes. Eriko received her Ph.D. in engineering with a focus in interventional cardiology and has published numerous peer-reviewed articles.