Associate Manager, Regulatory Affairs
Stryker Japan KKJob Description
The Job's Mission
Under minimum supervision by Manager, he/she understands the related laws and regulations, and efficiently conducts the duties such approval applications, notifications and other related tasks.
マネジャーの最小の指導の下、薬機法全般に精通し、豊富な知識と経験を有し、円滑な薬事申請及び関連業務の遂行を目的とする。
Key Activities & Accountabilities
Responsibilities of this job is the appropriate execution of approval applications/notifications for medical devices which Stryker Japan K.K. manufactures and distribute. The duties are as follows:
Manufacturing and distribution/certification approval, notifications (including planning, collecting data, and PMDA/NB query correspondence)
Maintenance of approvals and certifications (Change control and periodical renewal)
QMS compliance inspection applications
Insurance listing applications (Creation of insurance listing application forms)
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