Complaint Coordinator

Santen InnFocus, Inc. in Miami is looking for a Complaint Coordinator to join their team. The role is 100% on-site.

This role focuses on managing and processing product complaints related to the PRESERFLO MicroShunt. You will play a key role in ensuring compliance with regulatory standards while supporting product quality and continuous improvement.

What you will do

Complaint Handling & Investigation

• Receive and process product returns
• Perform testing and documentation on returned devices
• Conduct root cause investigations using production/QC data
• Determine reportability (e.g., adverse events) with internal teams

Cross-functional & Global Collaboration

• Communicate with global Santen entities
• Work with clinical, regulatory, and technical teams
• Handle sensitive information with professionalism

Documentation & Systems

• Maintain complaint databases and files
• Ensure accurate and timely data entry
• Document outcomes, corrective actions, and feedback

Compliance & Quality

• Ensure adherence to:
  • ISO 13485
  • EU MDR
  • 21 CFR Part 820
• Support internal/external audits
• Contribute to continuous improvement