Associate Manager, Regulatory Affairs

**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)

当社が製造販売する医療機器に係る下記を中心とした薬事申請業務の適切な履行を職責とする。

+ 製造販売承認／認証申請、届出（計画...