東京都 千代田区 国会議事堂前駅, 株式会社 JointHire Japan

仕事内容:

  • 仕事内容

確かな技術力に支えられた高付加価値商品を海外から輸入し、日本市場へお届けしています。

医療・量子部では、革新的な海外製品を輸入・販売することで、日本の医療の発展に貢献しています。

今後は、SaMD(Software as a Medical Device:プログラム医療機器)の取り扱いも順次拡大していく予定です。

化粧品原料部門では、世界各国から厳選した高機能・高付加価値・高独自性の原料を提供し、常に新しい価値を創造しています。

現在、医療機器や化粧品原料などの取扱製品の増加に伴い、薬事申請、品質管理、業態管理などの業務を担当していただける方を募集します。

(業務内容)

薬事申請等業務: 自社取扱い製品の登録/申請書の作成・提出/各種業態許可申請・更新・管理、保険適用申請など

1.製造販売業等業態の維持管理

2.医療機器の薬事承認申請業務(承認・認証・届出)

3.保険適用申請関連業務

4.添付文書/法定表示等の作成 、管理

5.監督官庁への月例報告資料作成、提出

品質保証関連業務: 品質システムの文書管理、更新/受入試験/外部監査等、各種監査対応/監督官庁への安全性情報報告等

1.化粧品原料等に関する品質管理全般、各種品質クレーム対応

2.医療機器の品質保証業務全般

(現在の取り扱い製品)

※詳しくは、ホームページを参照ください。

・医療機器

・ホルター心電図

・放射線治療用基準マーカー

・化粧品原料

応募要件:

  • 必須要件

・学歴:大学、大学院

・医療機器規制(薬機法等)の基本的な知識

・医療機器の薬事申請(認証・承認品目)経験(クラスⅠ~Ⅱ)

※「医療機器+ソフトウェア」の経験者:尚可

・保険適用希望書作成業務経験

  • 歓迎要件

・医療機器等、品質保証業務経験

・化粧品(若しくは原料)、化学品等の品質管理経験

・メーカーでの品質保証業務経験者

福利厚生・手当その他待遇:

  • 給与・待遇

月給 500,000円 ~ 700,000円

管理職手当:25,000万円/月

※時間外手当:無し

賞与 :普通賞与:基本給の1カ月分(12月)

業績賞与:基本給の1カ月~1.5カ月分程度(翌年2月)

昇給 :年1回(1月)

  • 福利厚生

通勤手当 :支給(上限50,000円)

有給休暇 :入社時付与、初年度12日(入社月に応じて按分)

社会保険完備

退職金 :有(3年以上在籍の社員が対象、確定拠出年金)

  • 休日・休暇

年間休日120日

完全週休2日制(土、日、祝日)、年末年始休暇、慶弔休暇、年次有給休暇、学校行事参加休暇

求人企業について:

  • 会社概要

1.メディカル関連事業

2.ファインケミカル事業

3.メンテナンスサービス

  • 会社情報

・業種 総合商社, 商社(その他)

・従業員数 50~100名



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