Health Authority Reporting Analyst
Core
Review and process product complaints, execute regulatory reporting to FDA and EU authorities, and manage Health Authority requests for medical devices.
Role type
Regulatory Reporting Specialist (Medical Devices)
Builds
Regulatory submissions and complaint management records for medical device manufacturers
Domain
Medical Devices / Regulatory Compliance
Deliverable
client delivery
Required skills
Regulatory reporting (FDA 21 CFR Part 803, EU MDR), complaint file assessment and closure, risk management documentation, audit support, stakeholder communication
Preferred skills
Knowledge of human anatomy and medical terminology, cross-functional collaboration, time management
Technologies
MS Office (Outlook, Word, Excel, PowerPoint), Microsoft Teams, Skype, Zoom, MD Workflow reports
Responsibilities
Assess and close complaint files, make regulatory reporting determinations (MDR/MDV), file Medwatch reports, manage Standard Health Authority Requests, support compliance audits, maintain Reportable Malfunction List
Seniority
Mid-level individual contributor
