Complaint Support Specialist

Noctrix Health is redefining the treatment of chronic neurological disorders with clinically validated therapeutic wearables. Our team of medical device specialists, neuroscientists, and consumer electronics engineers is dedicated to delivering prescription-grade therapy with an outstanding user experience. 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). Be part of our mission to transform healthcare, improve lives, and drive meaningful change with Noctrix Health. 

We’re seeking a Complaint Support Specialist who thrives in a regulated environment and can balance customer communication with compliance responsibilities. This role is responsible for managing and resolving complaints related to medical devices, serving as a liaison between the Therapy Support and Quality Assurance teams. You will investigate complaints, communicate directly with customers, document findings, and ensure adherence to FDA and ISO requirements. By collaborating cross-functionally, you will help address customer concerns and drive continuous product and process improvement. 

This position reports to the Therapy Support Manager. This is a full-time, fully remote role. 

Responsibilities: 

• Receive and review complaints related to medical devices 
• Investigate complaints by gathering relevant information, analyzing data, and conducting root cause analysis 
• Communicate directly with customers to solicit information, address concerns, and provide updates on complaint resolution 
• Serve as a liaison between Therapy Support and Quality departments to optimize customer satisfaction and maintain regulatory compliance 
• Ensure complaint investigations are complete, accurate, and closed in a timely manner 
• Collaborate with cross-functional teams – including Therapy Support, Quality, Regulatory, and Product – to resolve complaints 
• Ensure compliance with applicable regulations and standards, including 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 preferred in a relevant field such as biomedical engineering, life sciences, or related area; relevant work experience may be considered in lieu of a degree 
• 2+ years of experience in an FDA-regulated environment (drugs, biologics, medical devices, or related products) 
• 3+ years of experience communicating directly with patients or medical device customers 
• Detailed knowledge of ISO 13485 and GMP regulations governing medical device manufacturing 
• Strong analytical and problem-solving skills 

Qualifications: 

• Excellent verbal communication and interpersonal skills 
• Compassion, empathy, and patience when communicating with customers 
• Attention to detail and ability to manage multiple tasks simultaneously 
• Superior written communication and documentation skills, including presentations, spreadsheets, and reports 
• Ability to lead meetings and build consensus among cross-functional teams 
• Sound judgment with the ability to exercise independent discretion in execution of duties 

Compensation: 

• Base pay: $55,000–$75,000 per year + bonus