Job Summary

Responsible for reviewing customer inquiries and determining whether they meet the definition of a medical device complaint in accordance with global 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 organize and judge priorities.

•    Strong attention to detail.

•    Ability to work in a team environment

•    Required Skills and Competencies

•    Demonstrated knowledge of Microsoft Office

•    Effective written and verbal communication skills

•    Ability to generate and maintain accurate records

Education and Experience

•    Work experience in a technical and/or quality/compliance discipline/regulated industry, with data management, record keeping, and technical aptitude.

Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.