募集要項
- 募集背景
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<About the Position>
The focus is to complete and maintain regulatory approvals and clearances of assigned products.
- 仕事内容
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ESSENTIAL DUTIES AND RESPONSIBILITIES
- Regulatory impact assessment for change of existing products or new products
- Consult with regulators proactively to create regulatory strategies.
- Clarification of regulatory requirements and timelines with internal stakeholders
- Monitoring, analysis, and assessment of new local regulations and competitive products
- Review advertisement and promotional materials
- Create work instructions related RA process, if needed
- 応募資格
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- 必須
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- Knowledge for the PMD regulations, especially SaMD regulations.
- Understanding for standards of biocompatibility and electric safety tests.
- Scientific and logical thinking, Good Documentation Practice.
- Well understanding of risk management.
- Ability to work on multiple projects.
- Ability to collaborate with all levels of management and internal/external stakeholders.
- Bachelor or above degree for Engineering or Science is required.
- Minimum 10 years working experience in RA is required.
- Business proficiency in English (reading, writing, and conversation)
- Written and oral communications and ability to synthesize information to present internally as well as to regulatory agencies
- 歓迎
- - Work experience in an American or European company is desired.
- 雇用形態
- 正社員
- 勤務地
- 東京
- 年収・給与
- 1300万円~1500万円程度