募集要項
- 募集背景
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Position: Senior Regulatory Affairs Manager
Overview
We are seeking an experienced Regulatory Affairs and Safety Management Manager to join our team. This role involves managing regulatory compliance and safety operations for medical devices, ensuring adherence to PMD Act and other relevant regulations.
- 仕事内容
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Key Responsibilities
● Execute practical operations related to regulatory affairs and safety management
● Obtain Shonin approval and Ninsho certification for medical devices according to planned timelines
● Submit required regulatory notifications
● Manage QMS conformity inspections and surveillance inspections for product maintenance
● Handle procedures necessary for product marketing, including insurance coverage and compliance with related regulations
● Maintain regulatory documentation for approved/certified/notified products
● Oversee safety management operations
- 応募資格
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- 必須
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Required Qualifications
Education
● Bachelor's degree or equivalent
Experience
● Previous experience in regulatory affairs (RA)
● Safety management experience preferred
Language Skills
● English: Business level (reading, writing, and conversation)
● Must be able to communicate effectively with global team members in English
Core Competencies
● Strong communication skills for collaboration with internal departments, global manufacturers, and regulatory authorities
● Demonstrated problem-solving abilities
● Leadership capabilities in identifying challenges, planning, and execution
● Experience in cross-functional team coordination
- 雇用形態
- Full-Time/正社員
- ポジション・役割
- Senior Regulatory Affairs Manager
- 勤務地
- Saitama Prefecture / Chiba Prefecture / Tokyo / Kanagawa Prefecture
- 年収・給与
- 8 million yen ～ 11.99 million yen
