Post Market Surveillance Analyst

Job Description

Primary Function of the Position

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.

We have multiple openings for this position

Essential Job Duties

• Reporting to the Supervisor, Regulatory Post Market Surveillance
• 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 the 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.

Qualifications

Required Education, Training, Skills

• Undergraduate degree in engineering, life science, or equivalent 
• 4+ years’ experience in medical devices with strong understanding of complaint handling and regulatory processes 
• with regulatory post-market surveillance and complaint system knowledge 
• Familiarity with global regulatory reporting requirements (US FDA, EU MDR) and quality record standards 
• Excellent communication and analytical skills 
• Proficient in Microsoft Office and databases; able to manage workload independently and prioritize effectively