Supervisor MDR Remediation

Job Title:

Clerk Supervisor , MDR Remediation (FDA 483 Response)

Duration:

6 Months of contract

Location :

Mundelein, IL, 60060 (HYBRID - 3 Day Onsite )

Pay Range:

$35/hr - $40/hr

Day-to-Day:

Looking for a Supervisor , MDR Remediation, and manage a team of 20-25 employees supporting retrospective Medical Device Reporting (MDR) activities in response to FDA 483 observations. This individual will oversee end-to-end remediation workflows including reportability assessments, investigations, data gathering, MDR preparation, and submissions while ensuring compliance with 21 CFR Part 803, SOP-00048, and FDA reporting guidance. The Supervisor will establish team priorities, monitor throughput and quality metrics, provide real-time coaching and performance feedback, and serve as the escalation point for complex regulatory cases.

Must Haves:

5+ years of experience in medical device complaint handling, MDR reporting, or regulatory compliance 2+ years of direct people management experience Strong knowledge of 21 CFR Part 803 and MDR requirements Experience with complaint handling systems such as ETQ Reliance or TrackWise Experience supporting FDA inspections and CAPA activities Bachelor's degree in a scientific, engineering, or related field The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)