Hisako Hasegawa worked as a nurse for more than 10 years before becoming a clinical research associate (CRA) for a foreign-capital orthopedics company. She then joined the internal clinical development team in two medical device companies. In these roles, she earned more expertise and increased responsibility for clinical operations and obtaining Japanese regulatory approvals leveraging overseas clinical data. In her role at MCRA Japan’s Clinical Affairs team, Hisako manages the clinical portions of PMDA submissions, good clinical practice (GCP) audits and post-marketing surveillance (PMS) studies.