Noctrix Health - Complaint Support Specialist
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 • 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
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
Benefits
• Base pay: $55,000–$75,000 per year + bonus
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