Associate Manager, MedSurg, Regulatory Affairs

職務内容

マネジャーの最小の指導の下薬機法全般についての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

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

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プロジェクト管理資料取集PMDANB 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

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 project management 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)

Education

• 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
• Language Skills (he/she is able to read and write English)
• He/she has an ability to write the business documents

Experience

• 医療機器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
• 当局PMDA/MHLWとの相談事項の立案実行の経験があれば望ましい
• 医用電気機器に関する知識経験があれば望ましい
• 3 years of experience of medical device application approvals
• Good communications skills and project management skills
• Preferred if he/she has an experience of having PMDA/MHLW consultation meeting
• Preferred if he/she has knowledge/experience in Medical electrical equipment

Competencies

• 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
• 新しいことに挑戦する意欲を持った人材
• 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.
• He/she needs to have a challenge to inexperienced things