We are the people who give possibilities purpose
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
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 through accurate, efficient, and compliant complaint management. The Complaint Management Specialist also provides complaint detail to management, project teams and engineering, as requested.
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.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
To learn more about BD visit https://bd.com/careers
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.
Required Skills
Optional Skills
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BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its more than 70,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com.
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