A world-leading European dental medical device manufacturer is seeking a Regulatory Affairs Specialist in Tokyo. This role is responsible for managing regulatory approval processes for dental medical devices in Japan, ensuring full compliance with the PMD Act and local healthcare regulations.
You will work closely with government agencies and global headquarters, supporting product clearances that enable innovative dental technologies to reach patients and professionals across Japan.
Key Responsibilities
- Manage approval applications for dental medical devices in accordance with Japanese regulatory laws
- Liaise with regulatory authorities and government agencies to secure product approvals and clearances
- Coordinate with global headquarters to align international regulatory data and submission requirements
- Prepare and submit documentation related to national health insurance pricing and reimbursement processes
- Monitor regulatory changes and provide compliance training to internal teams
Required Skills and Qualifications
Experience:
- Experience managing regulatory affairs for Class II or higher medical devices
- Strong knowledge of Japan's PMD Act and medical device regulatory framework
- Ability to read and write technical regulatory documents fluently in Japanese
- Business-level English skills for communication with global offices
- Proven ability to prepare and submit official approval applications
Soft Skills:
- Strong attention to detail when reviewing technical documentation
- Effective communication and negotiation skills with regulatory authorities
- Proactive mindset to stay current with evolving regulations
Language Requirements:
- Japanese: Native-level fluency required
- English: Business-level proficiency required
Preferred Skills & Qualifications
- TOEIC score of 600+ is an advantage
- Experience in dental materials or dental equipment industries is a plus
About the Company
Our client is a prestigious European manufacturer with over 100 years of history in dental materials and equipment. They are globally recognised for high-quality ceramic solutions and advanced digital technologies supporting dentists and dental technicians worldwide.
Why You'll Love Working Here
- Join a world-leading global company with a strong employee-first culture
- Stable work-life balance with flexible morning start times
- Excellent job security supported by strong insurance programs
- Training opportunities at global headquarters and long-term career development
- Hybrid work options and a supportive Tokyo-based team environment
Don't Miss Out - Apply Now!
