What are the responsibilities and job description for the Medical Device Complaint Specialist position at Three Point Solutions INC?
Job Title: Medical Device Complaint Specialist
Client: Medical Device Manufacturing Company
Duration: 1 Year Contract
Location: Lafayette, CO 80026
Shift: 1st Shift | Onsite 4 Days/Week | Remote 1 Day
Job Summary:
The Associate MDR/Vigilance Specialist supports complaint handling and regulatory reporting for the Respiratory Interventions (RI) Operating Unit. The role ensures compliance with FDA, ISO, and international vigilance reporting requirements by maintaining accurate, audit-ready documentation and collaborating across technical and quality teams.
Key Responsibilities:
- Process and manage complaints in the Global Complaint Handling System per company and regulatory standards.
- Monitor post-market surveillance activities, including adverse event evaluation and follow-up.
- Prepare and submit MDRs and vigilance reports to regulatory authorities.
- Collaborate with internal teams (R&D, QA, Technical Service, Manufacturing) to ensure thorough complaint resolution.
- Document and classify complaints accurately to support trend and risk analysis.
- Maintain all complaint records in a state of audit readiness.
- Write investigation summaries and ensure regulatory compliance in documentation.
Required Skills & Qualifications:
- Strong analytical thinking and critical reasoning.
- Excellent attention to detail and documentation accuracy.
- Effective communication and collaboration with cross-functional teams.
- Bachelor’s degree in science, engineering, or a related field (preferred).
- Experience in medical device complaint handling or vigilance reporting (plus).
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