CT Product Safety Regulatory Engineer

Location Tokyo, Tokyo
Job type Permanent
Salary 6,000,000 - 10,000,000 JPY
Reference 33947

【COMPANY OVERVIEW】

 One of the largest medical device company in the world.

 【JOB RESPONSIBILITIES】

  • Working with global team and cross function engineers for new products.

  • Working with RA/QA team and external experts for ITS test of new products.

  • Working with RA/QA team for product audit activities.

  • Lead project execution by giving technical leadership.

  • Use technical expertise to align standards and regulatory requirements with products.

  • Driving impact assessments of updated IEC standard and regulatory requirements for each related country.

  • Driving the design and execution of system level tests for related system level requirements.

 【REQUIREMENTS】

  • Bachelor's degree in Computer Science, Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Physics, Medical Physics or a closely related field.

  • At least 7 years development experiences in clinical medical devices.

  • At least 5 years safety and regulatory related experiences for clinical medical devices.

  • Strength in IEC standard and product regulatory knowledge.

  • Fluent Japanese and business English to communicate with global teams and auditors.

  • For foreigners: must have a valid working visa already.

 【DESIRABLE】

  • Imaging / X-ray Medical device development experience.

  • Regulatory / IEC standard safety test experience.

 【FOR FURTHER INFORMATION】

  • Click apply

OR

  • Contact Jessica:

Jessica.sanusi@cornerstone.jp // 050 1751 6021