Tokyo 日機装(株) ¥7,000,000 - ¥9,000,000
【仕事内容】

(案件No100448)

透析装置、消耗品等、同社が扱う医療機器、医薬品のRA(薬事)の実務およびプロジェクト管理の業務

【具体的に】

・自社開発または導入の新規医療機器の薬事戦略の策定

・新規販売先国への薬事戦略の策定

・世界各国法規制動向の情報収集・調査

・海外規制当局が承認する薬事申請資料の作成/レビュー

・規制当局対応

・企画部門、設計開発部門に対する薬事・法規遵守の助言・支援

・PMDA、第三者認証機関、都道府県薬務課等行政との折衝・対応

・QMSの維持管理、品質監査対応

など

【組織】

・10名程度の組織です。

・能動、非能動医療機器について海外、日本国内を担当。日本国内医薬品も含む。

・チャレンジに寛容な環境で、様々な業務、改善にチャレンジできます。(その他詳細は面談でお伝えします)

【求める人材】

【MUST】

・海外、国内の医療機器のRA業務経験

・日常的に英語を使用して業務を行っている

【WANT】

・英語力(ビジネスレベル)

・医療機器の品質保証経験

・安全規格への対応経験

・行政との対応経験

・内資企業で海外との折衝経験(市販後の品質問題対応)

・QMSの経験

・設計経験、技術的な話ができるとなお良し

・滅菌に関する知識があるとなお良し

新しいことに対応することを厭わない方

※医療機器のRA業務の経験があれば、類似製品でない医療機器の経験で可

※業務を実行・達成する、問題解決するためにどうすればよいのか、考え、牽引できる方(その他詳細は面談でお伝えします)

【給与】

700~900万円

【勤務地】

東京都

【勤務時間】

求人紹介時に詳しくお伝えいたします。

【雇用・契約形態】

正社員

【待遇・福利厚生】

育児休暇制度/介護休職制度/借り上げ社宅制度/財形貯蓄/社員寮(独身寮)/退職金/社員持株会制度/資格取得奨励金制度

【休日・休暇】

土曜日/日曜日/祝日/年末年始休暇/夏季休暇/有給休暇/慶弔休暇/出産・育児休暇/完全週休2日制
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