Complaint Support Specialist

Responsibilities

• Receive and review complaints related to medical devices
• Investigate complaints by gathering information, analyzing data, and conducting root cause analysis
• Communicate directly with customers to address concerns and provide updates
• Serve as a liaison between Therapy Support and Quality departments
• Ensure complaint investigations are complete, accurate, and closed in a timely manner
• Collaborate with cross-functional teams including Regulatory and Product
• Ensure compliance with FDA 21 CFR Part 820 and ISO 13485
• Prepare for and participate in internal and external audits
• Contribute to cross-functional process improvement initiatives

Requirements

• Bachelor’s degree in biomedical engineering, life sciences, or related area (or equivalent experience)
• 2+ years of experience in an FDA-regulated environment
• 3+ years of experience communicating directly with patients or medical device customers
• Detailed knowledge of ISO 13485 and GMP regulations
• Strong analytical and problem-solving skills

Preferred Qualifications

• Excellent verbal and written communication skills
• Compassion, empathy, and patience when communicating with customers
• Ability to lead meetings and build consensus among cross-functional teams
• Strong attention to detail and ability to manage multiple tasks

About the Company

Noctrix Health is redefining the treatment of chronic neurological disorders with clinically validated therapeutic wearables. We have pioneered the world’s first drug-free wearable therapy, clinically proven to alleviate symptoms in adults with drug-resistant Restless Legs Syndrome (RLS).