シニアRAスペシャリスト/ Sr. RA Specialist

An international medical device company is seeking a Sr. RA Specialist. The selected candidate will support regulatory submissions, manage product approvals, and ensure compliance with local regulations.

Responsibilities:

• Prepare Shonin, Ninsho, and Class 1 Notifications based on agreed strategy
• Submit QMS documentation when necessary
• Support Class IV application processes and lead PMDA consultations with managerial guidance
• Conduct regulatory assessments for change control
• Maintain and manage registered Shonin documentation
• Interact with Japanese authorities and industry groups
• Manage reimbursement processes
• Review promotional materials and labelling

Requirements:

• Bachelor’s degree or above in a science background
• More than 5 years of RA experience in the medical device industry
• Prior experience with Class IV applications
• Skilled in negotiation with MHLW, PMDA, and Notified Bodies
• Proficient in MS Office Suite; ERP systems

About the Company:

A medical device manufacturer based in North America which produces and distributes clinical devices and services.

Keywords:

薬事申請, 医療機器, 承認管理, 規制対応, プロモーション資料, 変更管理, 償還申請, 求人, 外資系

Job Ref: HC8X21