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MDR complaint Specialist / Quality Specialist
Onsite Mundeline, IL
Need to be able to start onsite on the 25th
Essential Skills
MDR complaint Specialist / Quality Specialist
Onsite Mundeline, IL
Need to be able to start onsite on the 25th
Essential Skills
- At least 1 year of experience in complaint handling, MDR evaluation, or similar experience within a regulated industry.
- Working knowledge of FDA MDR regulations (21 CFR 803) and complaint handling requirements.
- Understanding of FDA Quality System Regulations, including 21 CFR 820 and complaint handling under 21 CFR 820.198.
- Hands-on experience reviewing product complaints to determine MDR reportability in compliance with FDA regulations.
- Experience managing high-volume documentation reviews or participating in large-scale remediation or retrospective review projects.
- Strong ability to interpret medical narratives, product information, and adverse event descriptions to assess severity, outcome, and reportability.
- Strong analytical skills and a high level of attention to detail.
- Ability to work effectively in a fast-paced environment and meet aggressive deadlines.
- Proficiency with electronic medical device records and documentation practices.
- Effective communication and collaboration skills for working with cross-functional teams.
- Bachelor’s degree in a relevant field is beneficial but not required.
- 2 years of MDR reporting or complaint remediation experience in a medical device or pharmaceutical environment is preferred.
- Experience working in remediation environments with aggressive deadlines and throughput expectations.
- Familiarity with complaint management systems such as SAP, TrackWise, or similar platforms.
- Experience supporting remediation or retrospective review efforts for regulatory compliance.
- Demonstrated ability to maintain organized records and documentation in support of audits and inspections.