Compliance Specialist 2
Core
Ensures timely post-marketing safety filings (GVP) and complaint handling documentation for medical devices, communicating with Japanese regulatory agencies.
Role type
Compliance Specialist (Medical Device Safety/Quality)
Builds
Regulatory submissions and quality management documentation for Intuitive Surgical products
Domain
Medical Devices / Regulatory Compliance (Japan)
Deliverable
client delivery
Required skills
Post-marketing safety filing expertise, complaint handling management, SOP creation and maintenance, regulatory agency communication, quality management system support, Japanese medical device regulations knowledge
Preferred skills
Cross-functional collaboration, technical documentation translation, continuous process improvement
Technologies
GVP, PAL, PMDA web systems
Responsibilities
Prepare and implement GVP in compliance with Japanese PAL; Collect and review local and overseas post-marketing safety information; Manage complaint handling filings and prepare customer letters; Communicate with head office on complaint cases; Support quality management activities with the QA team; Maintain SOPs for filing, complaint handling, and quality management; Document Package Inserts and maintain PMDA web pages
Seniority
Mid-level, hands-on IC
