募集要項
- 募集背景
- A global medical research organization is searching for a seasoned health science professional for the role of RA & QA Director. The successful applicant will manage the quality assurance and regulatory affairs department and ensure ongoing compliance of the company's quality system.
- 仕事内容
-
A global medical research organization is searching for a seasoned health science professional for the role of RA & QA Director.Responsibilities:
* Lead the quality assurance/regulatory affairs department
* Develop and define regulatory strategy and manage the regulatory submission process for new product development activities
* Work closely with relevant individuals/teams to resolve potential regulatory-related issues
* Handle PMDA submissions to ensure timely approvals and certification
* Support international regulatory staffs by providing business/product information to develop strategies and requirements
Requirements:
* Bachelor's degree in health science or a relevant discipline
* 3+ years' QA and RA experience in the medical device industry
* Native-level Japanese; proficiency in English
* Experience with international standards (g. ISO, GVP, etc.)
* Solid relationships with MHLW & PMDA
- 応募資格
-
- 必須
- 3+ years' QA and RA experience in the medical device industry
- 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 - JPY16,000,000.00 per annum
- 待遇・福利厚生
- 完全週休2日制、土日祝日休み、有給休暇
