Regulatory Affairs Specialist / Manager

Location Tokyo
Job type Permanent
Salary 8,000,000 - 12,000,000 JPY
Reference 32871

【COMPANY OVERVIEW】

Leading Life Science company focused on battling cancer through the use of its new technology in clinical, regulatory, and commercial solutions.

【JOB RESPONSIBILITIES】

As a Regulatory Affairs Specialist (or Manager), you will be responsible for activities which lead to and maintain regulatory approvals.

In addition, you will be responsible for assessment of device changes for regulatory implications for companion diagnostics and for regulatory risk determinations to assess the use of the device in clinical trials.

【WHY YOU SHOULD APPLY】

  • Work from home

  • Global team (US based)

  • Work with leading, new technology at the forefront of battling oncology disease

【REQUIREMENTS】

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

  • 2 years’ experience in regulatory affairs. IVD industry is preferred.

  • Strong organizational skills and attention to detail required.

  • Ability to work in a fast-paced/entrepreneurial team environment.

  • Results and goal oriented.