Sr. Associate - Regulatory Affairs - Operations 5B
On-site · China
Core
Manage medical device complaint inquiry records, determine complaint definitions, and conduct due diligence.
Role type
Senior Associate, Regulatory Affairs Operations
Builds
Inquiry records and complaint escalations
Domain
Healthcare / Medical Devices
Deliverable
dashboards & analysis
Required skills
Data Analytics, Lean Six Sigma, Collaboration Tools
Preferred skills
Regulatory Compliance Certifications
Technologies
GCHS, Auxiliary Systems
Responsibilities
Create, review, update, escalate, and close Inquiry Records in GCHS; Determine if Inquiry Records meet medical device complaint definitions; Conduct due diligence; Monitor records updates; Review auxiliary systems and import information into inquiries.