Complaint Management Specialist I

Job Description The Complaint Management Specialist I is responsible for executing end‑to‑end complaint handling activities, including intake documentation, regulatory assessment and reporting, and timely complaint closure in compliance with internal procedures and global regulatory requirements. The role supports patient safety, audit readiness and business continuity. Job Responsibilities Manage medical device complaint records end‑to‑end, from initial intake through final closure, ensuring accuracy, completeness, and compliance with internal procedures and regulatory requirements. Accurately document complaint information in the electronic complaint handling system and ensure appropriate classification and assessment. Acknowledge receipt of complaints and generate customer correspondence, including closure communications, as required. Complete, review, and approve regulatory decision trees to determine reportability. Prepare and submit regulatory reports, including MDRs and global vigilance reports, in accordance with applicable regulations and timelines. Monitor complaint progress to ensure timely closure by coordinating follow‑up activities, tracking product returns, and obtaining additional patient, product, or procedural information as needed. Perform complaint record closure activities and ensure all required documentation and regulatory obligations are met. Conduct sampling and review of closed complaint records to verify accuracy, consistency, and compliance. Interact with healthcare professionals, consumers, and internal stakeholders regarding product quality concerns, maintaining professional and effective customer communication. Demonstrate flexibility by managing multiple assignments and adjusting priorities in response to business and regulatory needs. Maintain strict confidentiality of patient information and complaint data in accordance with ethical and regulatory requirements. Comply with all BD quality policies, procedures, and practices through the consistent application of sound Quality Assurance principles. Perform other duties as assigned. 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. Location Primary Work Location: USA AZ - Tempe, BPV Building 4 Equal Opportunity Employer Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics. #J-18808-Ljbffr Becton Dickinson