Job Summary
The Medical Device Complaint Specialist is responsible for evaluating, processing, and investigating product complaints to ensure accurate assessments, regulatory compliance, and timely resolution. This role supports complaint handling activities through complaint coding, reportability determination, data analysis, documentation review, device history record evaluations, and basic failure analysis. The position works closely with cross-functional teams to support quality and regulatory objectives, identify potential adverse events, maintain accurate records, and contribute to continuous improvement initiatives. Success in this role requires strong analytical and organizational skills, attention to detail, and the ability to manage multiple priorities in a fast-paced, regulated medical device environment.
This position is integral to supporting the department through complaint handling, reportability determination, data analysis, trending, and documentation review, coordination of complaint and lot qualification data, device history reviews, review,



and closure of certain categories of complaints and work on complaint handling projects. It requires organization and attention to detail while working with other functions within the organization to ensure compliance and accomplishment of tasks.
Responsibilities:
• Analyze and process complaints in a uniform and timely manner, to ensure proper complaint coding and accurate complaint assessment.
• Assess complaint vigilance reportability for moderate risk complaints, utilizing system based decision trees
• Perform data entry and prepare reports / graphs related to special projects, complaints and lot qualification.
• Maintain accurate documentation and files related to special projects, complaints and lot qualification.
• Review and analyze lot documentation (DHR’s) to determine if there are any anomalies that may have related to reported product failures.
• Process feedback letters and communicate to product

📌 Medical Device Complaint Specialist (Guadalajara)
🏢 Insulet
📍 Guadalajara