Medical Device Complaint Specialist

Job Description

Job Description

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 :

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