Rieko Tanegashima, Ph.D.

Rieko Tanegashima, Ph.D.

Rieko Tanegashima, Ph.D.

Consultant

Rieko joined Parexel in October 2015 and is a consultant with significant regulatory expertise in medical devices. She has experiences in FDA regulatory of medical devices including writing, and developing strategies of RFDs, IDEs, 510(k) etc. She also has experience supporting PMDA pre-meeting and PMDA consultation in drug and regenerative medicine products. Rieko is also a well-trained scientist in molecular and cellular biology and the regenerative medicine area. Rieko utilizes her experiences and expertise to conduct Gap analysis in FDA and PMDA medical device regulatory to develop regulatory strategies and supports PMDA consultations including preparation of required documents.

Work Experience

Before joining Parexel, Rieko led projects for FDA regulatory approvals by writing and developing strategies of RFDs, IDEs, 510(k)s, preparing responses to FDA queries, and supporting meetings with FDA in medical device company. She achieved successful FDA approvals of haemostats, wound dressings and bone void filers. As chief scientist, she developed strategies and protocols of preclinical safety and efficacy evaluations for regulatory submissions. She managed and initiated clinical trials in US with CROs. She also conducted KOL interviews in EU for product development and supported to build regulatory strategy for CE marking.

Education

Rieko received a B.S. in Agricultural and Biological Chemistry from Nihon University in Tokyo, Japan in 1999. She received a Ph.D. in Cellular and Molecular Biology from Kent State University in 2005.

We are always available for a conversation.

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