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About the Role
This role serves as the Quality Responsible Person (Hinseki) and supports the operation and maintenance of the company’s Marketing Authorization Holder (MAH) framework in Japan. The position works closely with both local teams and overseas manufacturing partners to ensure quality compliance, manage customer complaints, and support broader regulatory and post-market quality activities.
Responsibilities
- Maintain and improve the Quality Management System (QMS) in compliance with Japanese regulatory requirements
- Manage customer complaints and coordinate investigations with global manufacturing partners
- Review, analyze, and evaluate quality information and recommend appropriate actions (CAPA, improvements)
- Communicate with regulatory authorities and manufacturing partners regarding quality matters
- Support regulatory affairs and post-market surveillance activities
- Collaborate cross-functionally to resolve quality-related issues
Requirements
- 3+ years of QA experience in the medical device industry in Japan
- Experience serving as, or supporting, a Quality Responsible Person (Hinseki) within an MAH structure
- Knowledge of the PMD Act and related quality regulations (QMS, GVP, etc.)
- Experience with active medical devices
- Knowledge of laser devices or regulated electrical equipment
- Familiarity with Electrical Safety Law and Radio Act
Skills
- Native-level Japanese communication skills
- Business-level English
Location
- Tokyo
Work Type
- Flexible work style
- Remote work
- Flexible office environment
- Full-time position
Experience Level
- 3+ years of QA experience
Education Level
- Bachelor’s degree in science, engineering, or related field
Salary/Compensations
- Competitive salary package (details shared confidentially)
Benefits
- Standard benefits
About the Company
- A global medical device company has recently established its Japan subsidiary and is expanding its local quality organization.