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【SPINE】Sr. Regulatory Affairs Specialist or Specialist_Regulatory Affairs Specialist

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Regulatory Affairs
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18000JFE Requisition #
Thanks for your interest in the 【SPINE】Sr. Regulatory Affairs Specialist or Specialist_Regulatory Affairs Specialist position. Unfortunately this position has been closed but you can search our 2,390 open jobs by clicking here.

Must Haves

Knowledge/Education

・理系大卒以上または同等の専門教育修了者以上

・医薬品医療機器等法に関する基本的な知識

 

Job Experience

・クラス2以上の医療機器における承認・認証申請の経験 3年以上

PMDA簡易相談、対面助言の経験

 

Skills /Competencies 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

・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

Job Experience

・工学系(機械、電気等)

・整形外科領域での薬事申請経験

PMDA簡易相談、対面助言の経験

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.
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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