One of the largest medical device company in the world.
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.
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.
Imaging / X-ray Medical device development experience.
Regulatory / IEC standard safety test experience.
【FOR FURTHER INFORMATION】
Jessica.firstname.lastname@example.org // 050 1751 6021