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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