Associate Manager, MedSurg, Regulatory Affairs
Stryker · Tokyo, Japan ·
- Category
- Legal
Work Flexibility: Hybrid or Onsite
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、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）
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