Hiroshi Ichinose

Hiroshi Ichinose has more than 30 years of experience managing regulatory and clinical strategy in the MedTech space and serves as the Director of the Regulatory Affairs team at MCRA Japan,  overseeing all facets of the regulatory submission process. During his tenure with MCRA Japan, Hiroshi has assisted companies across the full therapeutic spectrum, including orthopedic, dermatological, cardiovascular, neurological, ophthalmic, dental, urological, imaging and digital health. His primary area of focus is on high-risk Class III and Class IV devices.  

Prior to joining MCRA Japan, Hiroshi gained nearly 20 years of experience in R&D at a Japanese pharmaceutical company, working on clinical trial design, KOL engagement and the development of R&D related systems. He then joined the founding team of a U.S. medical device company's Japanese subsidiary and created the SOP for a good clinical practice (GCP) clinical trials in advanced wound care. Following regulatory approval, he designed and ran the post-marketing surveillance (PMS) study, established the safety management system, and became the company's Safety Manager. Hiroshi has acquired a broad range of experience in his more than 30-year career in areas including orthopedics, dentistry, surgical devices and pharmaceuticals.