Product Complaint Analyst III

This role analyzes customer feedback within the Complaint Management Center (CMC) to support complaint determination and regulatory reportability decisions. The Product Analyst III authors Medical Device Reports (MDR) and Medical Device Vigilance (MDV) submissions, ensuring compliance with GMPs and applicable regulatory requirements.

• Review regulatory assessments and provide feedback per CMC SOPs and WI
• Assess complaint communications for regulatory compliance, reportability, and patient safety impact
• Investigate complaints by gathering sufficient data from clinical, field, internal, and lab sources
• Establish regulatory reportability decisions using HA, DFMEA, and regulatory decision models
• Author MDR/MDV and other regulatory reports; ensure timely transmission

The technical scope centers on applying Hazard Analysis (HA) and Design Failure Mode and Effects Analysis (DFMEA) to complaint and event investigation outputs. The role produces MDR/MDV regulatory reports and communicates investigation results using CMC SOPs and WIs under 21 CFR Part 820, EU MDR, MDSAP, and ISO 13485.

The ideal candidate is a senior-level medical device quality/regulatory professional with strong complaint management experience and demonstrated knowledge of MDR/MDV regulatory workflows. They are able to apply Hazard Analysis (HA) and Design Failure Mode and Effects Analysis (DFMEA) to establish regulatory reportability decisions and write Medical Device Reports (MDR) while ensuring compliance with 21 CFR Part 820, EU MDR, MDSAP, and ISO 13485.