A world-leading European dental manufacturer is seeking a QA/RA Manager in Tokyo to oversee quality assurance and regulatory compliance across Japan. This is a high-impact leadership position responsible for ensuring product safety, maintaining ISO standards, and managing communication with both local authorities and global headquarters.
You will play a critical role in supporting the continued growth of an international medical device business while ensuring full compliance with Japan's strict healthcare regulations.
Key Responsibilities
- Act as the legally responsible manager for product quality and safety standards in Japan
- Ensure compliance with ISO 13485 and Japanese medical device regulatory requirements
- Lead the quality department and coordinate closely with global offices and headquarters
- Make final decisions on product releases and maintain detailed shipping and traceability records
- Manage product labels, safety data sheets, and official business licenses
- Handle product recalls, audits, and inspections conducted by government authorities
- Provide quality management training and oversee hazardous substance handling processes
Required Skills and Qualifications
Experience:
- Licensed pharmacist or university degree in chemistry, pharmacy, or related scientific field
- 5+ years of experience in medical device or pharmaceutical sales/manufacturing environments
- Strong background in quality assurance and regulatory affairs within Japan
- Business-level English ability for documentation and communication with global teams
Soft Skills:
- Strong communication skills to bridge local operations and international stakeholders
- Proven leadership ability to manage teams and deliver staff training
- High level of professional responsibility and attention to regulatory detail
Language Requirements:
- Japanese: Native-level fluency required
- English: Business-level proficiency required
Preferred Skills & Qualifications
- Experience within the dental equipment or dental materials industry
- Advanced knowledge of international quality standards such as ISO 13485
- Scientific bachelor's degree or higher strongly preferred
About the Company
Our client is a prestigious European manufacturer of dental materials and equipment with over 100 years of history. Known globally for high-quality ceramic solutions and advanced digital tools, the company supports dentists and dental technicians worldwide through innovation and excellence.
Why You'll Love Working Here
- Competitive compensation package with strong long-term stability
- Excellent job security and unique insurance benefits through retirement
- High level of autonomy and authority in the Japan quality function
- Direct collaboration with European global headquarters
- Flexible working arrangements including remote work and flex time
Don't Miss Out - Apply Now!
