Complaint Coordinator

Santen InnFocus 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

Qualifications :

What you will bring to the role

• Bachelors 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 $47031 - $70547 depending on experience.

   

Additional Information :

Grow your career at Santen

A career at Santen is an opportunity to make a difference. Through our long-term vision outlined in Santen 2030 we are committed to be a Social Innovator - addressing the social and economic needs of people with visual impairments. We have team members around the world using their diverse talents to unlock new modalities and drive innovations for patient outcomes education and treatment. At Santen we believe in empowering all our team members with flexible ways of working and a highly inclusive work environment.

The Santen Group is an Equal Opportunity Employer. We are committed to building diverse teams and ensuring a safe and inclusive physical and virtual workplace for every one of our team members. All employment decisions are based on business needs role requirements and individual qualifications regardless of race color ethnicity national origin/ancestry religion sexual orientation gender gender identity/ expression age disability medical condition marital status veteran status or any other characteristic protected by law.

If you require any kind of accommodation during our recruitment process please let the recruiter from our team know.

Remote Work :

No

Employment Type :

Full-time