Regulatory Affairs Senior Specialist

Location 東京都
Job type Permanent
Salary
Reference 35630

COMPANY OVERVIEW

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

JOB RESPONSIBILITIES

  • 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.

REQUIREMENTS

  • 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

FOR FURTHER INFORMATION

  • Click apply

OR

  • Contact Saloni:

saloni.dharne@cornerstone.jp