Medical Device Complaint & MDR Investigator

Medasource; Madison (WI); On-site; USD 65,000 - 90,000; Full time

Job summary

Medasource seeks a Complaint Handling Specialist to join its Quality team in Madison, WI. You will own the lifecycle of medical device complaints from intake through closure, coordinating investigations and regulatory reporting.

You will lead cross-functional investigations, perform MDR/vigilance determinations, and support CAPA/SCAR assessments to ensure timely regulatory submissions and complete documentation.

Qualifications

• Bachelor's degree preferred; equivalent professional experience will be considered.
• 2+ years of medical device complaint handling experience.
• Experience managing or supporting complaint investigations within a regulated medical device environment.
• Strong documentation, organization, and attention to detail.
• Ability to manage multiple investigations and regulatory timelines simultaneously.
• Proficiency with Microsoft Office or similar business applications.

Responsibilities

• Own the complaint lifecycle from intake through closure.
• Lead complaint investigations with cross-functional support.
• Coordinate supplier evaluations or device repairs as part of investigations.
• Perform MDR/vigilance determinations using FDA, EU MDR, and Health Canada criteria.
• Maintain FDA ESG account and submit eMDRs, FDA Form 3500A, and supplemental reports on time.
• Document risk assessments and CAPA/SCAR for complaints.
• Support CAPA initiation and investigation outcomes.
• Assist with root cause analysis and corrective actions.
• Prepare complaint metrics for Management Review.

Skills

Attention to detail

Documentation

Regulatory timelines management

Cross-functional collaboration

Education

Bachelor's degree

Tools

Microsoft Office

eQMS

ComplianceQuest

Job description

Medasource seeks a Complaint Handling Specialist to join its Quality team in Madison, WI. You will own the lifecycle of medical device complaints from intake through closure, coordinating investigations and regulatory reporting.

You will lead cross-functional investigations, perform MDR/vigilance determinations, and support CAPA/SCAR assessments to ensure timely regulatory submissions and complete documentation.