募集要項
- 募集背景
- A global manufacturer of medical devices is searching for a Head of Regulatory Affairs. In this role, you will be responsible for leading commercial activities in Japan such as product registration, quality assurance, and regulatory adherence.
- 仕事内容
-
A global manufacturer of medical devices is searching for a Head of Regulatory Affairs.Responsibilities:
* Improve commercial quality systems
* Hire and keep strong talent
* Manage and optimise quality and regulatory procedures
* Track performance and compare to the budget
* Maintain expertise on local regulatory information
* Perform product registration procedures in a timely manner
Requirements:
* Bachelor's degree or equivalent in a scientific field
* 10+ years of experience in an international matrix organisation
* 5+ years of experience as a general, quality, or safety controller for IVD or MED medical devices
* Valid pharmaceutical license
* Strong understanding of Japan IDV and MED products and regulations
* Native level Japanese; fluent level English
- 応募資格
-
- 必須
- 5+ years of experience as a general, quality, or safety controller for IVD or MED medical devices
- 歓迎
- 英語力必要。その他は詳細からご確認ください。
- 雇用形態
- Permanent
- 勤務地
- Tokyo
- 年収・給与
- JPY10,000,000.00 - JPY20,000,000.00 per annum
- 休日休暇
- 完全週休2日制, 土日祝日休み, 有給休暇