Jobs list of Medical Device & Regulatory Affairs (RA)
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Job number: JN -122024-181552 Posted: 2025-02-14
CMC Manager / CMC Specialist
ワークライフバランスを考慮した働き方の実現6 - 12 million yen Tokyo Medical Device Regulatory Affairs (RA)
- Company overview
- We are a provider of dental products and related services. We have developed a broad product lineup in the field of dentistry to meet the needs of dentists and dental technicians. In particular, we provide diagnostic and treatment instruments and materials necessary for dental treatment, as well as products utilizing digital technology, which are highly valued for their high quality and reliability. We are also actively involved in the latest trends and innovations in the dental industry to help improve patient outcomes and advance dental care. We are committed to strengthening our partnerships with the local community and contributing to better health through education and community activities.
- Responsibilities
- 業務内容：
歯科用医薬品の薬事申請業務
製品の変更管理、影響などの評価を行い、関連部門に報告する。内容により薬事対応も行う。
製造委託先及び外国製造所の管理業務
医薬品医療機器等法の要求事項を理解し、当社の品質システム文書への展開を行う。
関連部署と連携し、品質管理体制及び安全管理体制を現場に浸透させる。
主なコミュニケーション先製造委託先の品質保証、製造部門担当者
当社品質保証部門、製造部門、マーケティング、サービス部門担当者
Risa Harada
Medical Device -
Job number: JN -122024-180834 Posted: 2025-01-17
内視鏡開発のプロダクトマネージャー（Regulatory Affairs）
挑戦できる文化あり／課題解決に役立てる環境5 - 8 million yen Tokyo Medical Device Regulatory Affairs (RA)
- Company overview
- We specialize in the development, manufacturing, and distribution of medical and scientific equipment. We are particularly renowned for our expertise in fields such as endoscopy and digital camera technology. We prioritize quality and innovation in our products, playing a crucial role in the medical and research sectors. Furthermore, we tailor solutions to meet the needs of our customers, providing support to medical and research institutions worldwide.
- Responsibilities
- 本部署では、新製品開発における製品登録および既存製品に関する規制対応Regulatory Affairsの視点から担当します。グローバルコミュニケーションが必要で、R&D、QA、工場との連携しながら業務を遂行いただきます。
業務内容：
製品開発の初期段階から、Regulatory Affairsの視点で申請書類を作成サポート
海外での製品登録およびその他の地域での登録サポート
既存製品の市場維持のためのRegulatory Affairsサポート
海外拠点とのコミュニケーション
Shotaro Tsubaki
Medical Device -
Job number: JN -072024-168803 Posted: 2024-09-25
【大阪】薬事申請・事業開発
薬事申請経験者必見です!5 - 9 million yen Osaka Medical Device Regulatory Affairs (RA)
- Company overview
- Our client specialize in the development and sale of comprehensive functional materials, including optical films for crystal use. Leveraging polymer technology, we expand our business in various fields, guided by our "Global Niche Top" strategy. This strategy fosters a virtuous cycle, generating high-value-added products, supporting substantial research and development expenditures, and fostering innovative new technologies. We have a culture that encourages challenges and innovation, with no distinction between new graduates and experienced hires.
- Responsibilities
- 能動医療機器、プログラム医療機器の認証申請プロセスの管理と実行
医療機器の薬事戦略の立案と実行、規制当局との折衝
国内外の医療機器関連法規制の最新動向の追跡と分析
製品開発チームと協力し、規制要件を満たす製品設計の支援
【入社後まずお任せしたい業務】
認証申請業務
薬事、規制要件の調査、薬事戦略、保険戦略の立案
医療機器の製造販売業に関するQMS、GVP業務
医療機器の開発支援
Shotaro Tsubaki
Medical Device
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