募集要項
- 募集背景
- 欠員補充
- 仕事内容
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Work as a part of Regulatory Affairs team, supporting the introduction of medical devices.－ Develop an effective regulatory strategy for each project from a broad perspective and achieve active product introduction.
－ Develop logical thinking, simplify complex information, and provide logical explanation.
－ Proactively advance each project with skills to deliver powerful, compelling messages while maintaining good communication with various parties at the company, MHLW/PMDA and industries.
－ Understand PMDA/MHLW’s thinking and successfully negotiate for the benefit of the company and projects.
－ Enhance internal compliance and risk management system based on understanding of the Japanese PMD Act and other business－related laws and regulations.
- 応募資格
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- 必須
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－ More than 3 years’ experience of regulatory affairs for class I/ II/ III / IV medical devices in medical device company, or a Contract Research Organization （CRO）.
－ Business level English.
－ Strong interpersonal skills required in the areas of verbal and written communications, focus on regulatory bodies, appropriately responsive to service to internal business needs, coaching, influencing, and team building with growth mindset.
－ Strong listening and assessment skills.
－ Strong questioning ＆ problem－solving skills.
－ Must be self－motivated and self－disciplined and able to prioritize and handle multiple tasks and responsibilities.
- 歓迎
- － Experience of class III / IV medical device submission with clinical data is highly regarded. （Not essential）
- 募集年齢(年齢制限理由)
- 長期勤続によりキャリア形成を図るため （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
- 茨城県 / 埼玉県 / 千葉県 / 東京都 / 神奈川県 / 山梨県 / 大阪府 / 京都府 / 兵庫県
- 勤務時間
- 9:00 - 17:30
- 年収・給与
- 900万円 ～ 1100万円程度（経験・スキルに応じて相談可能）
- 選考プロセス
- 面接2回
