Complaint Management Specialist I
On-site · Tempe, Arizona, United States
Job Summary
The Complaint Management Specialist I is responsible for end-to-end medical device complaint handling, including intake documentation, regulatory assessment and reporting, and timely closure in line with internal procedures and global regulatory requirements. The role supports patient safety, audit readiness, and business continuity, and provides complaint details to management, project teams, and engineering. Responsibilities include managing complaint records from initial intake to final closure with accurate documentation, acknowledging receipts and generating customer communications, completing regulatory decision trees to determine reportability, submitting regulatory reports (MDRs and global vigilance), monitoring progress to ensure timely closure, coordinating follow-up activities, and maintaining confidentiality of patient information. Required qualifications include a Bachelor’s degree in a technical/scientific/healthcare field or equivalent experience, knowledge of FDA QSR 820, MDRs, ISO/GMP principles, strong data/documentation skills, ability to manage multiple records and meet regulatory timelines, and excellent written and verbal communication in professional English.
Required Qualifications
- Bachelor’s degree in a technical, scientific, healthcare, or related field OR a minimum of 5+ years of relevant experience in complaint handling, quality, regulatory, or a regulated healthcare/medical device environment
- Strong working knowledge of complaint handling principles and regulated quality systems
- Proficiency with advanced computer applications, including electronic databases, spreadsheets, and word processing tools
- Knowledge of FDA Quality System Regulation (21 CFR Part 820), Medical Device Reporting (21 CFR Part 803), ISO standards, and Good Manufacturing Practices (GMP) principles
- Demonstrated attention to detail with the ability to accurately document, review, and maintain complex and confidential data
- Ability to prioritize workload and manage multiple complaint records while meeting regulatory timelines and business metrics
- Strong organizational, analytical, and problem-solving skills
- Experience handling sensitive, confidential patient and product information in a compliant and ethical manner
- Skilled in clear, concise communication, both written and verbal, including professional business English usage, grammar, spelling, and punctuation
- Ability to read, write, and understand English
- Effective interpersonal and customer communication skills when interacting with healthcare professionals, customers, and internal stakeholders
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