Complaint Handling Specialist

Position Summary

We are seeking a detail-oriented Complaint Handling Specialist to join our Quality Assurance team. This role is responsible for supporting and managing medical device complaint activities, including intake, documentation, triage, investigation, regulatory assessment support, and timely closure of product complaints. The Complaint Handling Specialist will help ensure complaint files are accurate, complete, audit-ready, and compliant with applicable internal procedures, FDA Quality System requirements, ISO 13485, and other applicable regulatory expectations.

Key Responsibilities

• Receive, document, and triage incoming product complaints in accordance with internal procedures and applicable regulatory requirements, including FDA 21 CFR 820, ISO 13485, and other relevant complaint handling expectations.
• Manage assigned complaints through the complaint lifecycle, including intake review, documentation, investigation coordination, follow-up, and timely closure.
• Conduct or support complaint investigations by gathering and reviewing relevant information from customers, internal teams, manufacturing records, device history records, product return evaluations, and other available sources.
• Evaluate complaints for potential reportability and support timely preparation of MDR, vigilance, or other regulatory reporting documentation, when required.
• Coordinate with cross-functional partners, including Customer Care, Regulatory Affairs, Manufacturing, R&D, Clinical, and Quality Engineering, to obtain information needed for root cause analysis, risk assessment, and complaint closure.
• Ensure complaints are accurately logged, tracked, updated, and closed in the electronic complaint handling or quality management system within required procedural and regulatory timelines.
• Escalate potential serious injury, death, hospitalization, product risk, recurring issues, or potential CAPA triggers to appropriate Quality, Regulatory, and Management stakeholders.
• Ensure complaint files are complete, clearly documented, technically sound, and inspection-ready.
• Support complaint trending, metric reporting, and preparation of information for management review and continuous improvement activities.
• Participate in internal audits and support external regulatory inspections, as needed.
• Perform other duties and quality system tasks as assigned.

Required Qualifications

• 1-2+ years of experience in complaint handling, quality assurance, regulatory affairs, customer quality, or a related function in a regulated environment.
• Strong documentation skills with the ability to write clear, accurate, and objective complaint records.
• Excellent attention to detail, organization, time management, and follow-through.
• Strong written and verbal communication skills, including the ability to work with cross-functional teams.
• Ability to prioritize work and manage deadlines in a fast-paced, regulated environment.
• Proficiency with Microsoft Office, including Excel, Word, and Outlook.

Preferred Qualifications

• Bachelor's degree in science, engineering, healthcare, or a related field, or equivalent combination of education and experience.
• Experience in the medical device, pharmaceutical, biotechnology, healthcare, or other FDA-regulated industry.
• Familiarity with FDA Quality System requirements, ISO 13485, MDR reporting, vigilance reporting, or other post-market surveillance requirements.
• Experience using a quality management system, complaint handling system, CRM, or other electronic case management platform.
• Experience reviewing product return evaluations, manufacturing documentation, device history records, or similar technical records.

Key Competencies

• Regulatory documentation discipline and commitment to data integrity.
• Critical thinking and ability to assess incomplete or ambiguous complaint information.
• Sound judgment in identifying high-risk complaints and escalation needs.
• Ability to work independently while maintaining alignment with Quality, Regulatory, and operational procedures.
• Continuous improvement mindset and ability to identify recurring complaint themes or process gaps.