医療機器 安全管理業務
Core
Ensuring timely post-marketing filings (GVP) and complaint handling for medical devices while maintaining documentation and communicating with regulatory agencies.
Role type
Senior Safety Control Specialist (Medical Device Regulatory)
Builds
Regulatory submissions and safety documentation for Intuitive Surgical products
Domain
Medical device regulation / Japanese pharmaceutical and medical device law (PAL)
Deliverable
client delivery
Required skills
GVP preparation and implementation, post-marketing safety information review, complaint handling management, SOP creation, regulatory agency communication, quality management system maintenance
Preferred skills
Cross-functional collaboration, technical documentation translation, continuous process improvement
Technologies
PMDA web systems, Intuitive Surgical Product Development Process
Responsibilities
Prepare and implement GVP in compliance with Japanese PAL, collect and review local and overseas post-marketing safety information, manage outsourced contractor daily work, handle complaint filings and prepare customer letters, support quality management activities with the QA team, maintain SOPs for filing and complaint handling, document Package Insert and maintain PMDA web pages
Seniority
Senior, hands-on IC
