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【SPINE】Regulatory Affairs Specialist or Sr Regulatory Affairs Specialist

📁
Regulatory Affairs
📅
20000KU7 Requisition #
Thanks for your interest in the 【SPINE】Regulatory Affairs Specialist or Sr Regulatory Affairs Specialist position. Unfortunately this position has been closed but you can search our 1,336 open jobs by clicking here.

 

Must Haves

 

Knowledge

・医薬品医療機器等法に関する基本的な知識

 

 

Job Experience

・医療機器における承認・認証申請の経験があるとなおよい

PMDA簡易相談、対面助言の経験があるとなおよい

 

 

 

Skills/Competency Required

英語力製造元と日常的なメール/電話会議等でのやり取りが発生するため 

コミュニケーション能力

・自己管理能力

 

 

 

Computer Skills:

PowerPoint/Word/Excel

 

 

 

Nice to Have

 

Job Experience

・生物由来製品に関わる経験

 

 

 

Skills/Competency Required

TOEIC 650点以上

 ・生物学、生物分子学の知識

 

 

 

 

 

 

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