【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