Job Summary
Responsible for reviewing customer inquiries and determining whether they meet the definition of a medical device complaint in accordance with integral regulations and complaint handling procedures. This role supports complaint intake, categorization, reassessment of records when new information is received, and accurate documentation to ensure compliance and effective reporting. Requires experience in a regulated environment (quality, compliance, or technical field), strong attention to detail, record management skills, effective communication, and the ability to manage multiple priorities in a team-oriented environment. English proficiency and Microsoft Office skills are required.
The Complaint Determination Associate will work under the guidance of the Team Lead, Complaint Determination, who is a leader within Global Product Monitoring. This individual will execute a process to ensure compliant complaint determination decisions are made. This person is responsible for completing all aspects of the complaint determination process.



They will follow established global regulations and processes for complaint determination.
Responsibilities
• Review and execute the process to determine if an inquiry record meets the definition of a medical device complaint
• Assign cases, determined to be complaints, with an appropriate category to allow for better assignment at the next phase of the complaint handling process.
• Assign cases, containing non-complaint feedback, with an appropriate category to allow for better trending and reporting activities.
• Reassess inquiry records when new information is received
Performs other complaint handling responsibilities as required
Required Leadership/Interpersonal Skills & Behaviors
• English language proficiency is mandatory.
• Ability to handle team interpersonal conflicts and find an acceptable resolution
• Proven experience to organize, prioritize and follow through on multiple tasks with minimal supervision
• Ability to

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