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Job description
The Job's Mission
Under minimum supervision by Manager, he/she understands the related laws and regulations, and efficiently conducts the duties such approval applications, notifications and other related tasks.
マネジャーの最小の指導の下、薬機法全般に精通し、豊富な知識と経験を有し、円滑な薬事申請及び関連業務の遂行を目的とする。
Key Activities & Accountabilities
Responsibilities of this job is the appropriate execution of approval applications/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)
当社が製造販売する医療機器に係る下記を中心とした薬事申請業務の適切な履行を職責とする。
- 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）
Education
- Language Skills (he/she is able to read and write English)
- He/she has an ability to write the business documents
- 語学力（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。
Experience
- 3+ years of experience of medical device (Class I to IV) application approvals
- Experience of PMDA consultation, and application approvals of improved device (preferably Class IV)
- Good communications skills and project management skills
- 医療機器（クラスＩ～ＩＶ）の薬事申請における3年以上の実務経験
- PMDA相談経験及び改良医療機器（クラスＩＶであれば望ましい）の薬事申請経験
- 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
Competencies
- 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.
- Please describe in detail the history of approval / certification application and the role you played in your resume.
- 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
- 職務経歴書に、承認・認証申請の履歴と担った役割を詳細に記載してください。