募集要項
- 募集背景
- 欠員補充及び新規製品導入の需要による新ポジション
- 仕事内容
-
Exciting opportunity to play an integral role in introducing new product/solution, maintain regulatory compliance and leading transformation/improvement activities.
- Develop local regulatory strategy and lead the strategic discussion with related stakeholders to accelerate project development.
- Proactively identify risks within regulatory strategies, plans, products and propose alternate approaches.
- Plan and execute product registration aligned with local business needs.
- Maintain current registration approvals accordingly.
- Manage interactions with MHLW/PMDA and maintain a productive working relationship.
- Review/Author product registration document and reimbursement document.
- Proceed regulatory assessment and promotional material review.
- Supervise RA administration activities.
- Lead various transformation/improvement activities.
- 応募資格
-
- 必須
-
- +7 years’ experience in medical device regulatory affairs.
- Maintains general knowledge of PMD act, ISO 13485, Radio act.
- Actual experience of authoring SaMD medical device submission and received approval.
- Self-motivated and able to prioritize handling multiple tasks/responsibilities.
- Bachelor of Science Degree in a technical discipline. (master’s preferred)
- Fluent in Japanese and business level of proficiency in English.
- 歓迎
- - Actual experience of authoring class III / IV medical device submission including SaMD and received approval.
- 募集年齢(年齢制限理由)
- 長期的によりキャリア形成を図る為 （長期勤続によりキャリア形成を図るため）
- 雇用形態
- 正社員
- 勤務地
- 埼玉県 / 千葉県 / 東京都 / 神奈川県 / 山梨県
- 勤務時間
- 9:00 - 17:30 (完全フレックスタイム制)
- 年収・給与
- 1000万円程度～ 1200万円程度（経験、能力による）
- 選考プロセス
- 面接2~3回
