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【Spine】_Sr Regulatory Affairs Specialist

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Regulatory Affairs
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19000HLQ Requisition #
Thanks for your interest in the 【Spine】_Sr Regulatory Affairs Specialist position. Unfortunately this position has been closed but you can search our 465 open jobs by clicking here.

Must Haves

Knowledge/Education

・大卒以上

・医薬品医療機器等法に関する基本的な知識


Job Experience

・クラス3以上の医療機器における承認・認証申請の経験4年以上

PMDA簡易相談、対面助言の経験


Skills /Competencies Required

・英語力、TOEIC600点レベル以上(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

・薬事的なものの捉え方、考え方が出来る

・業務に積極的に、かつ、誠実に取り組む姿勢


Computer Skills:

PowerPoint/Word/Excel


Physical Requirements:

宿泊を伴う国内及び海外出張が可能なこと


Nice to Have

Knowledge/Education

・理系バックグラウンド


Job Experience

・工学系(機械、電気等)

・整形外科領域での薬事申請経験


Skills /Competencies Required

TOEIC600点レベル以上

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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.
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