Complaint Support Specialist

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