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.

We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!

Position Overview
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
• 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
Solid understanding of QSR and/or ISO 13485 preferred
Demonstrated knowledge of Microsoft Office
Working knowledge of complaint handling functions of a medical device company preferred
Working understanding of TrackWise and SalesForce CRM preferred
Effective written and verbal communication skills
Ability to generate and maintain accurate records

Education and Experience
• Experience in medical device complaint handling, or related field preferred

Additional Information
• The position can be remote, hybrid or in-person. The preferred location, if in person, is the Acton, Massachusetts facility.
• Travel is estimated at less than 5 percent, but will flex depending on business needs.