募集要項
- 募集背景
- We are seeking a QA/RA leader to oversee the quality and regulatory aspects of our innovative IVD products in Japan. The role involves maintaining a high standard of quality, managing regulatory documentation, and supporting registration processes for new and existing IVD licenses. The ideal candidate will be passionate about addressing unmet medical needs and ensuring compliance with relevant standards.
- 仕事内容
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Seeking QA/RA leader for IVD products in Japan. Maintain quality, manage docs, support registrations. Ideal candidate passionate about medical needs, ensures compliance.Role Description
● Ratio – QA 70% / RA 30% (RA projects to be supported by external consultant)
● Act as Document Control Center to handle all quality and regulatory documents related to applicable standard for Quality Management System.
● Prepare, register, and gather documents related to registration process to get both new and renew IVD licenses.
- 応募資格
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- 必須
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Minimum Requirement
● Licensed pharmacist
● +3 years of experienced in QA
● Business level Japanese / Conversational English
Preferred Requirement
● Distinctive problem solving, organizational, and analytical skills
● Ability to influence multiple stakeholders without direct authority
● Experience in IVD/ Medical device
- 雇用形態
- Full Time/正社員
- ポジション・役割
- Quality Assurance & Regulatory Affairs Manager
- 勤務地
- Saitama Prefecture / Chiba Prefecture / Tokyo / Kanagawa Prefecture
- 年収・給与
- 8 million yen ～ 9.99 million yen
