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

🔍 Tokyo, Japan

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Regulatory Affairs
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18000JFE Requisition #
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Feb 04, 2019 Post Date
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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