Jobs in Japan
Explore hand-picked jobs in Japan for English speakers across tech, education, marketing, and more.
Vetted companies only. Apply from overseas.
Jobs in Japan
Explore hand-picked jobs in Japan for English speakers across tech, education, marketing, and more.
Vetted companies only. Apply from overseas.
This job posting was originally in Japanese. The English version is automatically translated. Please visit the company site for the most accurate information.
Bringing medical technologies developed at the global forefront to the Japanese market. As a Regulatory Affairs Specialist/Senior Specialist, you will be responsible for medical devices (Classes I–IV), from approval strategy through post-market management, and will be involved throughout the entire product lifecycle. Beyond handling submissions, you will join projects from the early stages of development and lead market launches aligned with business strategy while ensuring rigorous compliance. This position is also open to candidates who wish to apply experience gained in R&D, product development, or QA to the regulatory affairs field. You can broaden your expertise by drawing on a range of skills, from reading and understanding research to organizing information logically and documenting it. Responsibilities include preparing, reviewing, and submitting regulatory application documents for medical devices (Classes I–IV), including approval applications, supporting documents, and QMS conformity assessment applications; liaising with the Pharmaceuticals and Medical Devices Agency (PMDA) and the Ministry of Health, Labour and Welfare, and responding to inquiries; developing regulatory strategies and managing submission schedules from the product development stage; maintaining regulatory compliance after launch, including minor change notifications, partial change applications, and periodic reports; monitoring regulatory developments and sharing information internally; maintaining SOPs; conducting internal training; and collaborating with overseas headquarters and global teams.
- Bachelor's degree or higher in life sciences or a related field. - Excellent communication, negotiation, and presentation skills. - Logical thinking and problem-solving skills. - Ability to work proactively and responsibly. - Japanese: Native-level proficiency; English: Business-level proficiency
- At least 3 years of experience in regulatory submissions for medical devices or pharmaceuticals for the Specialist role, or at least 5 years for the Senior Specialist role. - In-depth knowledge of Japanese regulations related to medical devices, including the PMD Act, QMS Ministerial Ordinance, and GCP. - Experience liaising with the PMDA and certification bodies. - Project management skills, required for the Senior Specialist role.
- A company culture that supports learning, growth, and success through in-person collaboration. - A company culture where you can learn, grow, and thrive.
