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【800～1000万円】Regulatory Affairs 担当
| Hiring Company | 非公開 |
| Location | Tokyo - 23 Wards |
| Job Type | Permanent Full-time |
| Salary | 8 million yen ~ 10 million yen |
Job Description
【求人No NJB2396763】
1）QMS構築のリード
（１）QMS文書体系のゼロからの設計
（２）SOP整備・教育・内部監査
（３）認証取得（ISO13485）に向けたロードマップ策定
2）MAH（製造販売業）取得に向けた準備
（１）製造販売業の許可要件のギャップ分析
（２）品質保証責任者・安全管理責任者の要件確認
（３）外部委託（製造所・試験機関）との品質契約整備
3）研究機関認定の取得プロジェクト推進
（１）倫理審査委員会の設置
（２）研究計画書・手順書の整備
（３）労働省への申請書類作成・折衝
4）申請戦略の立案
（１）医療機器・IVDの承認申請に向けた規制戦略
（２）PMDAとの事前相談
General Requirements
| Minimum Experience Level | No experience |
| Career Level | Mid Career |
| Minimum English Level | Business Level |
| Minimum Japanese Level | Native |
| Minimum Education Level | Bachelor's Degree |
| Visa Status | Permission to work in Japan required |
Required Skills
【基本要件】
・医療機器または体外診断用医薬品（IVD）のRA実務経験5年以上
・QMS（ISO13485）構築・運用経験
・医療機器製造販売業（MAH）の立ち上げ経験
・ISO13485認証取得経験
・PMDA相談経験
・医療機器、IVDの承認申請経験
・厚生労働省「研究機関」認定の経験
・ドキュメンテーション能力の高い方
・自走できる方
Job Location
- Tokyo - 23 Wards
Work Conditions
| Job Type | Permanent Full-time |
| Salary | 8 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 | Pharmaceutical |
Job Category
Company Details
| Company Type | International Company |
