Cancer treatment software

●　Responsible for compliance with regulatory requirements as well as for documentation and administration of regulatory and QA. Collaborate with international QA/RA team outside of Japan.

Main Tasks:
●　Consultation to PMDA regarding Shonin
●　Filing minor change notifications
●　Help with QMS inspections and investigation of applicable laws and regulations

●　Knowledge in regulatory processes in Japanese medical laws and regulations.
●　5 year’s experience of working with regulatory affairs
●　Knowledge of Japanese medical regulations and applicable standards
●　Acquisition of Class 3, or higher, medical devices
●　Knowledge and experience of MS Office package
●　Japanese in native level
●　Experience working in an international environment is preferred
●　Excellent communication and organization skills
●　Self-management and self-organization