Mayumi Takeuchi

Mayumi has 30+ years of experience in Quality Assurance in the medical device and pharmaceutical industries. She currently serves as Senior Director of Quality Assurance, Post‑Market Safety Vigilance, and Logistics at Vorpal, where she oversees a wide range of Designated Marketing Authorization Holder (DMAH) processes.

Prior to joining Vorpal, Mayumi spent over 15 years as the Quality Officer and Safety Officer at a medical device company serving as the Marketing Authorization Holder (the entity legally responsible for product quality and regulatory compliance). In these roles, she led initiatives to strengthen quality systems under Japan’s Pharmaceuticals and Medical Devices Act (PMD Act) and consistently achieved high evaluations in obtaining and renewing licenses for Marketing Authorization Holders, manufacturers, and distributors/lessors. She is highly experienced in managing risk planning, inspection readiness, corrective and preventive actions (CAPA), and product recall operations, working effectively with regulatory authorities to take timely and appropriate measures. 

Mayumi has also served as an internal auditor for a global company, conducting audits in Japan and overseas. She is well-versed in EU and FDA regulations and has driven assessments, corrective guidance, and standardization based on the Medical Device Single Audit Program (MDSAP). As a first‑class (instructor-level) ISO auditor, she has contributed significantly to strengthening audit frameworks and QMS and post-market safety systems to support products after launch.