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  • Lead Specialist, Regulatory Affairs Japan
  • Stryker in Japan, , Japan
  • jobs
  • 1 week ago

jobs description

Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our RA/QA team the opportunity to learn new things, as well as endless growth opportunities! If you are interested in working at one of the World’s Best Workplaces, apply now !

Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team

【Main Responsibilities】

- 製造販売承認申請/認証申請/届出

- QMS適合性調査申請

- 承認/認証/届出/定期QMSの維持管理

- 保険適用希望書

- 上記に係る一連の業務:

+ 製品に応じた薬事戦略の策定

+ 設計製造所からの資料入手、必要に応じて追加試験の立案

+ MHLW/PMDA/NBとの照会回答、相談実施

+ 変更管理の評価

+ 販促物の確認

【Must Haves Job Experience】

+ 医療機器の薬事業務経験5年以上

+ 海外との業務遂行経験(テレカン等)

+ クラスⅢ以上の承認申請業務経験

【Must Haves Skills/Competency】

+ 薬機法及び関連法規に関する理解

+ 実務上の担当者としてPMDAと密接に折衝を行った経験を有する

... 組織において、日本語及び英語で、良好かつ円滑なコミュニケーションが取れる能力

+ 英語TOEIC 650点以上

+ 基本的なPCスキル(word, excel, power pointは問題無く使えること)

+ 新たな製品知識やシステムを学ぶ意欲

+ 年齢、性別に関係無く、他者の意見を聞くことができる

+ 自ら進んで問題解決に臨める

【Nice to Haves Job Experience】

+ 血管系もしくは非血管系インターベンション製品の薬事業務経験

+ 対面助言もしくは簡易相談の実務経験

+ Access DB, Power BI, Photoshop,Visioのスキル

About Stryker

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at stryker.com. (http:)

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability
Japan

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