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Regulatory Affairs
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19000DUI Requisition #
Thanks for your interest in the 【RTG】_Regulatory Affairs Manager position. Unfortunately this position has been closed but you can search our 2,213 open jobs by clicking here.

Must Haves

Knowledge/Education

学士以上


Job Experience

・薬事業務経験7年以上

・ピープルマネジメント経験

・ディスポーザブル系医療機器の申請業務経験、機械系医療機器の申請業務経験

・クラスIII以上の医療機器の承認取得経験およびクラスIIの医療機器の認証取得経験

・臨床あり品目の申請経験あれば尚可

・対面助言等行政との折衝経験

・海外製造元との折衝経験、駐在経験あれば尚可

・TOEIC 750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)

 

Skills/Competency Required

・薬機法、関連法規等に関する成熟した理解

・マルチタスク遂行能力、調整力、完遂力

・ピープルマネジメント能力

・論理的思考力

・海外カウンターパートとの業務遂行経験

・円滑なコミュニケーション能力

 

Computer Skills

PowerPoint/Word/Excel


Physical Requirements

宿泊を伴う国内・海外出張が可能なこと(ET/ENT RAは大阪、東京の2拠点のため国内出張が定期的にあります)

 

Nice to Have

 

Backgroundナビゲーションやソフトウェア製品の知識、経験

Skills/Competency: プロジェクトマネージスキル


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