Regulatory Affairs Senior Specialist

勤務地 東京都
業界・業種 医療・製薬
契約タイプ Permanent
参照番号 35630


A leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics.


  • Lead to and maintain regulatory approvals for In Vitro Diagnostic (IVD) devices and medical devices.

  • Lead in planning regulatory strategy for Japan.

  • Assist in meeting and consultation activities to gain PMDA’s feedback.

  • Acquire and stay up to date with knowledge on applicable regulatory requirements and scientific/technical issues of assigned projects.


  • B.S./B.A. in a science, engineering, or related technical field.

  • At least 3 years’ experience in regulatory affairs in Pharma, IVD and medical devices industry. CDx regulatory experiences are preferred.

  • Fluent Japanese and Business Level English