RA Specialist (domestic and Europe)

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Job details

Company overview

We are engaged in the medical field, specializing in clinical diagnostics. As a leading company in the industry, we provide valuable technologies and biomarker products. Our mission is to create new value in the healthcare market and contribute to the future of health and medicine. Since successfully commercializing products such as the syphilis test kit "Syphilis HA Antigen (TPHA)," we have been involved in research, development, manufacturing, and marketing, bringing innovation to the global clinical diagnostics industry. Particularly as a leading company in the field of immune sera, we have significantly contributed to medical advancement through the development of highly sensitive automated immunoassay instruments and dedicated reagents, as well as the development of rapid immunodiagnostic kits. We have garnered worldwide attention by swiftly succeeding in the development of a rapid antigen test kit for the novel coronavirus (SARS-CoV-2), demonstrating our commitment to providing highly socially impactful and necessary products.

Responsibilities

• 体外診断用医薬品・医療機器の薬事申請業務
• 業許可関連登録管理業務
• 薬事関連規制情報収集
• その他法規制対応

Requirements

Must:

• 体外診断用医薬品または医療機器の薬事申請業務経験者（3年程度）
• 業許可関連登録業務経験者

Better:

• 体外診断用医薬品の臨床研究経験、開発経験、学術経験、品質管理／品質保証経験者、三役経験者、海外薬事経験があれば尚可

Salary

6 - 9 million yen

Location

Tokyo