Edwards Lifesciences Veterans Jobs

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Edwards Lifesciences Sr Analyst, Reg Compliance in Tokyo, Japan

薬機法のコンプライアンスやQMSの運用に関連する下記の業務を行います。

① QMS調査、製造販売業許可・製造所登録の維持管理

  • 承認前/定期QMS調査申請および調査対応、実地調査時のコーディネート

  • 外国製造業登録新規申請、変更届の提出、更新申請

  • 製造所の定期的な確認

  • 外国製造所に対する規制要求事項の周知徹底

  • 規制要求事項遵守のための社内体制およびプロセスの維持、改善

  • 製品標準書の作成、変更管理

② 社内におけるQMSの運用

  • 事務局としてのQMSの維持・改善活動

  • QMSプロセスの運用(主にトレーニング、インターナル/エクスターナルオーディットなど)

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.

For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.

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