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RA Specialist
| Hiring Company | 外資医療機器メーカー |
| Location | Tokyo - 23 Wards |
| Job Type | Permanent Full-time |
| Salary | 7 million yen ~ 10 million yen |
Job Description
【求人No NJB2424940】
・ クラスI～IIIの医療機器について、海外メーカーから製品情報を収集・検討
・ 規制要件に適合した市場参入戦略を確実にするため、薬事申請・承認取得に向けた計画を策定・調整
・ 薬事申請用資料およびSTED（技術文書概要）を作成
・ 規制当局からの照会事項（Deficiency Letter）や追加情報提供の求めに対応・管理
事業許可の申請（許認可の取得・更新）を管理し、社内関連部門と連携して規制当局による監査や査察を支援
General Requirements
| Minimum Experience Level | No experience |
| Career Level | Mid Career |
| Minimum English Level | Business Level |
| Minimum Japanese Level | Native Level |
| Minimum Education Level | Bachelor's Degree |
| Visa Status | Permission to work in Japan required |
Required Skills
【Skill】
・医療機器規制関連業務（クラスII～III）において、主要担当者として3～5年以上の実務経験
・規制当局からの指摘事項（照会）に対する回答を、単独で作成・最終化する能力
・ライフサイクルおよび変更管理：市販後変更管理および研究開発試験データのレビューに関する豊富な経験
Job Location
- Tokyo - 23 Wards
Work Conditions
| Job Type | Permanent Full-time |
| Salary | 7 million yen ~ 10 million yen |
| Work Hours | 09:00 ～ 18:00 |
| Holidays | 詳細は求人ご紹介時にご案内いたします。 |
| Industry | Medical Device |
Job Category
Company Details
| Company Type | International Company |
