Description
BD is hiring a Senior Regulatory Specialist in Tokyo to lead regulatory strategy and submissions for medical devices from Class I through Class IV across the product lifecycle. The role covers PMDA and Ministry of Health, Labour and Welfare coordination, regulatory strategy, submission scheduling, post-market regulatory maintenance, regulatory updates, SOP development, training, and collaboration with global teams. Applicants need a bachelor's degree or higher in life sciences or a related field, strong communication and problem-solving skills, native Japanese and business-level English, and preferably more than three years of medical device or pharmaceutical regulatory submission experience.
