Back office analyst (Medical devices)

Job Summary

Supports the Complaint Handling team by reviewing, analyzing, and processing product complaints to ensure timely assessment, accurate coding, and compliance with regulatory and quality requirements. This role is responsible for determining reportability for low-risk complaints, maintaining complaint documentation, supporting data analysis and trending activities, and coordinating complaint-related projects. The position requires strong attention to detail, organizational skills, and the ability to work cross-functionally in a fast-paced environment while maintaining accurate records and meeting compliance standards.

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 low-risk complaints, utilizing system-based decision trees 
• Maintain accurate documentation and files related to special projects, complaints and lot qualification 

• Performs other duties as required. 

Education and Experience/ Minimum Requirements: 
• High school and/or equivalent combination of education and experience 

Preferred Skills and Competencies 

• Complaint handling experience preferred   
• Effective verbal and technical writing skills. Ability to communicate at multiple levels  
of an organization. 
• Ability to organize and judge priorities. 
• Excels at generating and maintaining organized and accurate records. 
• PC skill, word processing, spreadsheet, database. 
• Able to work effectively in a high-stress, high-energy environment. 
• Able to make decisions quickly based on vague or imperfect information and evaluate the need to obtain clarification and direction when necessary. 
 
 

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.