Tokyo Medtronic
JOB TITLE: Regulatory Affairs Specialist
DEPARTMENT:QRA CST SPN 担当
REPORTING TO:Regulatory Affairs Manager
LOCATION:Tokyo
Main Mission of Job
新製品の本邦への導入及び既存製品の維持管理を行うことで、医療現場に品質及び安全性の高い製品を提供する。
Main Responsibilities
A Day in the Life
Medtronic SPINE 事業部では、超高齢社会において増加し続ける椎間板ヘルニアや腰部脊柱管狭窄症、骨粗鬆症による圧迫骨折など、脊椎疾患の治療に用いる脊椎インプラントや骨補填材料、バルーンを用いた矯正など、新しい手術手技やソリューションを提供しています。薬事業務をとおして、様々な経験の出来るチャレンジングな分野です。
主な業務内容:
• 製品の特性に即した薬事申請戦略の立案
• 医療機器の薬事申請関連業務(届出、認証、承認)
• 当局又は認証機関との折衝(照会対応、対面助言を含む)
• 関連学会、医師との連携
• 保険収載業務(保険適用希望書作成等)
• 米国製造元及び社外及び社内関連部署との連携及び協力体制の構築
Must Haves
Nice to Have
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 :
• 医療機器における承認・認証申請の経験 3 年以上
• PMDA 対面助言の経験
• 材料系埋め込み医療機器の経験
• 臨床ありの薬事申請経験
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 )
• 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
• コミュニケーション能力(自身のPJのみならず、チーム内の課題を解決するため、或いは新しい通知への対応について、積極的にメンバーと協働できること。物怖じせず率直に意見を述べることができ、他者にも配慮できること。など)
• 品川オフィスに出社可能であること
• TOEIC 650 点以上
• 工学系(化学、機械、電気、ソフトウエア等)
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

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