Tokyo Biene フルタイム

仕事の詳細

医療機器製造業者および製造販売業者の総括製造販売責任者として、薬機法に基づいた国内医療機器QA業務を担当します。主な業務は以下のとおりです。

主な仕事

  • 医療機器製造販売業および医療機器製造業の許可取得予定
  • 日本本社と韓国JLK本社との連携
  • 医療機器製造販売業および製造業ライセンスの取得、更新、維持管理
  • 製造施設のQMS体制の構築とJGMP認証取得

必要な資格

  • 医療機器業界でのISO13485に基づく品質関連QA業務経験(3年以上)
  • 物理学、化学、生物学、工学、情報学、金属学、電気学、機械学、薬学、医学、または歯学に関する大学専門課程修了者
  • 国内医療機器法規、ISO13485、ISO14971、JGMPに関する知識

給与

2200万円~2600万円(経験・スキルに応じて決定します)



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