募集要項
- 募集背景
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Position: Regulatory Affairs Specialist
Regulatory Affairs Specialist in Japan, focusing on maintaining regulatory compliance for medical devices, in vitro diagnostics, and animal health products. The role involves managing licenses, conducting quality management system activities, and overseeing good vigilance practice operations.
Key responsibilities include collaborating with internal teams, implementing regulatory training, reviewing promotional materials, and handling inquiries from international offices and customers. The ideal candidate should be highly motivated and ready to contribute to a world-class team dedicated to advancing scientific research and improving global health and safety.
- 仕事内容
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Key Responsibilities:
● Maintain regulatory licenses and perform QMS activities for IVD/MD/AH products under the PMD Act.
● Oversee GVP operations for Medical Device, IVD, and Animal Health products in Japan.
● Collaborate with internal stakeholders for cross-functional discussions and GVP operations.
● Implement regulatory training, including planning, material creation, and record management.
● Manage reviews of promotional materials.
● Address inquiries from international offices and customers.
- 応募資格
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- 必須
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Required Experience & Skills:
● Experience in RA/QA within the pharmaceutical, medical device, or IVD industry.
● Knowledge of Japanese regulatory requirements.
● Business Level English
Preferred Skills & Experience:
● Experience responding to QMS conformity surveys
● Experience with safety related activities
● Experience using document management systems
- 雇用形態
- Full-Time/正社員
- ポジション・役割
- Regulatory Affairs Specialist
- 勤務地
- Tokyo
- 年収・給与
- 6 million yen ～ 8.99 million yen
