Hiroaki Hyakutake

Hiroaki Hyakutake has extensive experience in regulatory affairs and quality assurance, currently serving as RA/QA at LPixel Inc. since September 2018. Previously held the position of RA Manager at Medical U&A, Inc., where responsibilities included managing a team of six in Regulatory Affairs, leading Class III product submissions, and successfully navigating PMDA meetings to avoid clinical studies. Earlier roles include RA Specialist at KCI KK, focusing on submissions and audits, and QA/RA Specialist at Create Medic Co., Ltd., where Hiroaki dealt with certifications and complaint investigations. Hiroaki began a career in product development at STT Inc., specializing in market research and regulatory compliance for environmentally hazardous substances.