Complaint Coordinator

Responsibilities

• 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
• What you will bring to the role
• Bachelor's degree or equivalent experience
• Minimum 5 years' experience in the medical device industry
• Knowledge of ISO 13485, EUMDR, and 21 CFR Part 820
• Experience with complaint handling or returned goods preferred
• Strong MS Office skills (Word, Excel, PowerPoint, Outlook)
• Understanding of ophthalmic terminology is a plus
• Strong communication and organizational skills
• Fluent in English (written and spoken) What we offer:
• The salary range for the Compliant Coordinator position is $ 47,031 - $ 70,547 depending on experience.
• Grow your career at Santen
• If you require any kind of accommodation during our recruitment process, please let the recruiter from our team know.

Benefits

Additional Information

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.

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