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【CRHF】_Regulatory Affairs Specialist

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Regulatory Affairs
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19000IAB Requisition #

DEPARTMENT: JAPAN  Reguatory Affairs CVG group CRHF&AFS team

REPORTING TO:  REGULATORY AFFAIRS MANAGER 


Main Mission of Job

薬事行政に精通したエキスパートとして、米国本社および国内関連部門と協調して、効率的かつ効果的な申請戦略の立案、適時適切な製品情報の収集、薬事法令を遵守した質の高い申請実務の実行推進、行政当局との調整・折衝を行うことにより、担当部門製品の薬事承認取得とその適合状況の維持、並びに保険適用に責任を持ち、日本国内への新製品の速やかな上市と安全使用の推進に貢献する。


Main Responsibilities

・新製品のタイムリーな国内導入に向け、その製品特性、開発計画、市場およびビジネス上のニーズ、上市戦略を理解し、米国本社および関連部署と協力して、薬事承認および保険に関する申請戦略を立案する

・薬事申請戦略および作業計画に基づき、米国本社および国内関連部門の協力を得て必要な情報を収集し、行政当局との相談を行いながら、質の高い申請書を効率よく作成し、審査当局に提出し、承認取得する。

・製品の変更情報に対する評価

・保険適用業務

・添付文書作成並びに維持管理

・製品マスタ登録業務

・販促物(カタログ等)の内容確認

・その他 薬事関連業務の進行


Must Haves

・学士(4年制大学卒)以上又はそれに相当する学位、資格保持者

・TOEIC 800点以上(英語でのコミュニケーションに不自由のないこと)

・3年以上の薬事経験

・薬機法、関連法規等に関する基本的な理解

・的確な文章表現能力(日本語・英語)

・マルチタスク遂行能力、調整力

・プロジェクトマネジメント能力

・論理的思考力

・コミュニケーション/交渉力

・海外カウンターパートとの業務遂行経験

・一般的なPCスキル(Word, Excel, PowerPoint)製品知識を習得する学習能力

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Change Begins With You

We look for bold ideas and fresh insights - that's what drives innovation. Come drive the future of healthcare with us.

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The opportunity to invent. The benefit of joining a leader. The power to improve lives. You’ll find all that and more here.

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Join us in our challenge to make global healthcare more affordable and accessible. Your insight and oversight will help us create solutions that change the world.

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Medtronic Mission.

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Alyse is an Engineering Program Manager for Neuromodulation in Minneapolis, Minnesota.

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The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.
Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers.

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MEDTRONIC

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