Senior Specialist (薬事) - Tokyo - Stryker Corporation

Date de publication : 9/25/2019

Résumé de l'offre

Description de l'offre

The Job's Mission

Under minimum supervision by Manager and Lead Specialist, he/she understands the laws and regulations, and efficiently conducts the duties such approval applications, notifications and other related tasks.


Key Activities & Accountabilities

Responsibilities of this job is the appropriate execution of approval apprications/notifications for medical devices which Stryker Japan K.K. manufactures and distribute. The duties are as follows:

  • Manufacturing and distribution/certification approval, notifications (including planning, collecting data, and PMDA/NB query correspondence)
  • Maintenance of approvals and certifications (Change control and periodical renewal)
  • QMS compliance inspection applications
  • Insurance listing applications (Creation of insurance listing application forms)


  • 製造販売承認/認証申請、届出(計画立案、資料取集、PMDA/NB 照会対応)
  • 承認/認証の維持管理業務(変更管理、定期更新)
  • QMS適合性調査申請
  • 保険収載業務(保険適用希望書作成等)


  • Language Skills (he/she is able to read and write English)
  • He/she has an ability to write the business documents
  • 英語による文語でのコミュニケーションが実施できる。
  • ビジネス文書を書くスキルがある。


  • 3+ years of experience of medical device (Class I to IV) application approvals
  • Good communications skills and project management skills
  • Preffered if he/she has knowldge/experience in Vasclar products
  • 医療機器(クラスI~IV)の薬事申請における3年程度の実務経験
  • コミュニケーションスキル、プロジェクトマネジメントスキル
  • Vascularに関する知識・経験があれば望ましい


  • Not only high level of expertise required to the job, he/she needs to show a good communication skill in the organization. He/she can utilize the skill and communicate efficiently with internal related sections such as QC, WA, Sales & Marketing, Operations, Customer Care and etc.
  • He/she needs to have integrity and action-oriented mindset.
  • 業務に必要な専門性のみならず、組織の中で、円滑にコミュニケーションが取れる人材。社内関連部門(薬事、品質保証、品質管理、営業、マーケティング、オペレーション、カスタマーケア等)との良好かつ円滑なコミュニケーションが実施できる。
  • 誠実な対応、率先して行動できる人材

Work From Home: No

Travel Percentage: Up to 25%

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