What are the responsibilities and job description for the Assoc MDR/Vigilance Spec - Exempt position at Three Point Solutions INC?
Job Title: Assoc MDR/Vigilance Specialist
Client: Medical Device Manufacturing Company
Location: Lafayette, CO 80026
Duration: 1 Year
Shift: Onsite
Position Overview
The Associate MDR/Vigilance Specialist will support complaint handling, adverse event reporting, and regulatory compliance activities for medical devices. This role ensures accurate documentation, complaint investigations, and regulatory submissions in alignment with FDA and global requirements.
Key Responsibilities
- Intake, evaluate, process, and investigate complaints/adverse events per company procedures and regulations.
- Serve as primary contact for complaint reporting; ensure accuracy and compliance in Medical Device Reports (MDRs).
- Maintain systems to ensure all complaint investigations are completed and documented per policy.
- Support projects enhancing complaint handling processes and regulatory reporting requirements.
- Provide technical expertise to optimize complaint management and reporting systems.
Qualifications
- Education: Bachelor’s degree (preferred in Science, Healthcare, or Engineering).
- Experience: 0–2 years in complaint handling, quality systems, vigilance, or related medical device/pharma role.
- Strong administrative, documentation, and reporting skills.
- Ability to work independently with general supervision.
- Proficiency in English, typing, and technical writing.
Preferred Skills (Nice to Have)
- Knowledge of medical terminology, databases, and regulatory reporting systems.
- Familiarity with Good Documentation Practices (GDP), Good Manufacturing Practices (GMP), and Quality Systems in a regulated environment.
- Experience with complaint management software/tools.
- Strong communication skills for cross-functional collaboration.
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