仕事内容:
【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
アピールポイント:
セティ株式会社は、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。
求める人材:
〈必須〉
・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/尚可
〈歓迎〉
・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
勤務時間・曜日:
09:00〜17:45
休暇・休日:
★年間休日120日以上★
■完全週休2日制
給与:
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)
待遇・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)
福利厚生 :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)
その他:
本求人は、ライラック株式会社(ライフアップジョブ事業)が職業安定法に基づき、有料職業紹介事業として雇用企業をご紹介させていただく案件です。(許可番号:27-ユ
C
雇用形態: 正社員
給与・報酬: 7,000,000円 (年俸) 以上
平均所定労働時間(1か月当たり): 163時間
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