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| 部署・役職名 | Senior Regulatory Affairs Manager |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
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. 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 |
【必須（MUST）】 Required QualificationsEducation ● 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 |
| リモートワーク | 可 「可」と表示されている場合でも、「在宅に限る」「一定期間のみ」など、条件は求人によって異なります |
| 受動喫煙対策 | 屋内禁煙 |
| 更新日 | 2024/11/19 |
| 求人番号 | 4050162 |
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- 会社規模101-500人
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転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です