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賃金: ご相談可能
雇用形態: Permanent

会社概要

Cancer treatment software

仕事内容

● 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

応募資格

● 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

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