Health Authority Reporting Analyst

📋 Description

• Review and process product complaints via multiple channels.
• Support FDA and EU regulatory reporting.
• Manage complaint investigations and documentation using MD Workflow.
• Coordinate with sites to finalize complaint files.
• File MedWatch and MDV reports within timelines.
• Assist with audits and regulatory requests as needed.

🎯 Requirements

• 2-4 years related experience in medical devices or quality.
• Baccalaureate or higher degree in Science, Health or Engineering.
• Knowledge of FDA 21 CFR Part 803, MDR, MDV and EU regs.
• Fluent English, strong written and verbal communication.
• Ability to work cross-functionally in a matrix environment.
• Excellent attention to detail and problem solving.
• Experience with complaint handling systems and documentation.