Complaint Support Specialist

🕒 May 22

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Noctrix Health, Inc.

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2018

⚕️ Healthcare Insurance

🧬 Biotechnology

☁️ SaaS

Healthcare Insurance • Biotechnology • SaaS

Noctrix Health, Inc. is a pioneering company focused on developing next-generation, clinically validated wearable therapeutics aimed at managing chronic neurological disorders. With a mission to address the unmet needs of individuals living with such conditions, Noctrix combines expertise from seasoned medical device experts, neuroscientists, and engineers to deliver innovative therapies that enhance user experience. The company's flagship product, Nidra, has received FDA Breakthrough Device Designation and is designed for conditions like Restless Legs Syndrome, representing a promising advancement in wearable health technology.

📋 Description

• 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