|職務内容||〇 Prepare Shonin or Ninsho Application / Partial Change Application / Class 1 Notification based on the strategy agreed with the RA/QA Manager
〇 Prepare the QMS submission if necessary
〇 Support the regulatory assessment of change control as necessary
〇 Manage and maintain Shonin documents registered in Japan
〇 Interact with Japanese authorities and Medical Industry Groups
〇 Manage reimbursement
〇 Review of promotional materials and labeling
|応募資格||【Education and Experience】
〇 Minimum level of education needed to perform duties. Science back ground is preferred.
〇 Minimum 5 year RA experience in Medical Device Industries. Class 4 experience is preferred.
〇 Clinical experience (at CRO, etc.) is preferred.
【Essential Skills and Abilities】
〇 Excellent verbal and written communication skills
〇 Ability to multiple tasks, prioritize and work under pressure
〇 Strong negotiation skills with Japanese authorities (MHLW, PMDA, Notified body)
〇 Business level English (written and verbal)
〇 Computer skills – MS-Word, Excel, PowerPoint, ERP system (preferred)
〇 Good organization skills and ability
〇 Team spirit