Medical Device Complaint Analyst

Insulet Corporation; Región Centro; Presencial; MXN 240.000 - 360.000; Jornada completa

Descripción de la vacante

Insulet Corporation is seeking a Complaint Determination Associate to review customer inquiries and determine whether they meet the definition of a medical device complaint under global regulations. You will support intake, categorization, and reassessment of records with accurate documentation to ensure compliant reporting.

The role requires experience in a regulated environment, strong attention to detail, and effective communication.

Formación

• Experience in a regulated environment (quality, compliance, or technical field).
• Strong attention to detail and ability to manage records.
• Effective written and verbal communication skills.

Responsabilidades

• 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

Conocimientos

English language proficiency

Attention to detail

Multitasking

Team collaboration

Effective communication

Educación

Experience in regulated environment (quality/compliance/technical)

Herramientas

Microsoft Office

Descripción del empleo

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. 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! Insulet Corporation is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. (Know Your Rights)

Insulet employees are all focused on the same goal — to make a difference. Our relentless passion is to simplify life for people with diabetes. We excite and empower employees to bring their best selves to work through a culture that supports a healthy work and life balance. We set the bar high to meet customer needs, and our priority is to ensure our employees are equipped and supported to help us get there. We foster and celebrate curiosity, innovation, and learning. Our teams work collaboratively and are empowered to drive the best actions for our customers. Our innovation spirit and customer-centric focus position us as global pioneers — leading the way to improve health outcomes with revolutionary medical devices while breaking down barriers to access.