What are the responsibilities and job description for the Complaint Specialist position at Lendex Technology?
Job Overview
Candidates should have hands‑on experience reviewing product complaints and determining MDR reportability in accordance with 21 CFR Part 803. Experience working in remediation or retrospective review projects is strongly preferred.
Responsibilities
- Review historical and current complaint files to confirm completeness and reassess MDR reportability decisions.
- Apply FDA MDR definitions and decision criteria to determine whether an MDR should have been filed.
- Identify missing or unclear information in complaint records and work with Quality, Regulatory, Operations, and other teams to obtain needed details.
- Prepare and submit MDRs through the FDA eMDR system when reportable events are identified.
- Support compliance with FDA Quality System Regulations, including complaint handling requirements under 21 CFR 820.198, while meeting tight remediation timelines.
Requirements
- 1 year of MDR Remediation/MDR reporting experience
- Bachelors degree is preferred but not required
Pay: $25.02 - $30.13 per hour
Expected hours: 40.0 per week
Benefits:
- Health insurance
- Paid time off
Experience:
- MDR reportability: 1 year (Required)
- 21 CFR Part 803: 1 year (Required)
Ability to Relocate:
- Mundelein, IL 60060: Relocate before starting work (Required)
Work Location: In person
Salary : $25 - $30