Product Complaint Associate

Primary Function:
The Post Market team at Intuitive works at the intersection of Regulatory and Quality. The team processes complaints including meeting our global regulatory requirements. The post market team works cross-functionally to understand product safety and performance and facilitate the execution of robust resolutions. Functions collaborating with the Post Market Surveillance team include Field Action, Data Analytics, Clinical Engineering, Field Service, Technical Support, Customer Service, Risk Management, Service Operations, and Failure Analysis Engineering.
The Post Market Surveillance team requires an Analyst with post market surveillance experience and expertise in analyzing and processing medical device complaints. The position requires excellent verbal and technical writing skills, and passion for the best practices to analyze and process complaints.
Roles and Responsibilities:
Reporting to the Supervisor, Regulatory Post Market Surveillance, the Regulatory Post Market Surveillance Analyst is responsible to:
Perform the preliminary classification of complaints and escalate complaints that require additional review.
Complete follow-up with the customer or reporter via phone and email to gather additional information required for complaint investigation, including retrieval of RMA
Partner with subject matter experts on various activities related to complaint investigations, escalated field events, or regulatory response letters.
Evaluate complaints for global regulatory reporting in accordance with company procedures and Regulatory requirements
Review product analysis investigation and determine cause / contribution of event to device
Accurately select Risk (Hazard, Harms, Severity) and IMDRF codes
Escalate complaints that require additional review to product quality, manufacturing and design engineering teams as required
Evaluate documentation for completeness and consistency and identify additional actions as necessary to close the complaint file.
Approve final complaint file for closure after all applicable actions are completed
Participate in new hire training and continuous Regulatory Compliance training as required
Participate in process improvement activities to continuously improve process effectiveness
Perform other duties as directed
Skills/Job Requirements:
Education: Undergraduate degree in engineering, life science, or equivalent
Experience – 5 + years of experience in medical device field, with experience in the following areas:
Working understanding of regulatory post market requirements for Medical Devices, complaint system, and process requirements for post market surveillance.
Working understanding of regulatory quality records requirements and how they apply to complaint files and regulatory reports.
Working understanding of worldwide regulatory reporting requirements. (US FDA requirements, EU MDR requirements, etc.).
Training/Competencies:
Understanding of world-wide regulatory reporting requirements for Medical Devices and complaint system and process requirements preferred
Firm understanding of quality records requirements and how they apply to complaint files.
Able to make decisions quickly using information at hand and evaluate the need to obtain clarification and direction when necessary.
The following skills are required for this position:
Demonstrated strong written and verbal communication skills
Strong computer skills (Excel, Word, PowerPoint, database)
Excellent organizational and analytical skills
Ability to handle and manage workload independently
Prioritize numerous activities in a rapid paced environment
Working Conditions
This position requires the ability to complete most of the workday using a computer.

Skills
Data Analysis, Excel, Process Improvement, Technical Writing, Risk Management, Regulatory Compliance, Documentation

Experience
5+ yrs

Employment type
Full-time

Work arrangement
Hybrid