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Supervisor Post Market Surveillance - Medical Devices
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Dexian
Libertyville, IL (In Person)
$64,480 Salary, Full-Time
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Job Description
Supervisor Post Market Surveillance - Medical Devices at Dexian Supervisor Post Market Surveillance - Medical Devices at Dexian in LIBERTYVILLE, Illinois Posted in 3 days ago.
Type:
full-timeJob Description:
Job Title :
Medical Device Complaint Handling Supervisor Location :
Mundelein Illinois Pay range : $30 - $32Duration :
12+ MONTHS The Supervisor, MDR Remediation leads a high-volume team supporting retrospective Medical Device Reporting (MDR) activities in response to FDA 483 observations. This role manages 20-25 direct reports across multiple functions and ensures timely, compliant, and audit-ready MDR determinations and submissions in accordance with 21 CFR Part 803 andSOP-00048.
The Supervisor is responsible for driving execution, standardizing decision-making, and ensuring consistency across reportability, investigation, and submission activities. Key Responsibilities- Lead, manage, and develop a team of 20-25 employees across screening, investigation, and MDR submission functions
- Establish clear roles, responsibilities, and performance expectations
- Set and monitor daily and weekly output targets aligned to remediation timelines
- Conduct routine performance assessments, including throughput, accuracy, and rework trends
- Provide targeted, real-time feedback to drive quality and efficiency
- Oversee end-to-end MDR remediation workflow, including: Reportability assessment Investigation and data gathering MDR preparation and submission
- Ensure adherence to standardized workflows, including a structured 4-phase remediation model
- Ensure all MDR decisions align with o 21 CFR Part 803 o
SOP-00048
o FDA reportability guidance- Review outputs for accuracy, completeness, and consistency with risk files and established criteria
- Enforce standardized language justification for reportability decisions
- Implement and maintain standardized processes, templates, and tools
- Ensure consistent use of malfunction matrices and MDR numbering conventions
- Serve as escalation point for complex or ambiguous cases
- Partner with Clinical, Regulatory, and Quality teams to resolve issues and support decision-making
- Track and report key performance metrics, including throughput, timeliness, and quality trends
- Provide regular updates on remediation progress, risks, and resource needs
- Support audit readiness, CAPA effectiveness monitoring, and FDA inspection activities
- Ensure team training completion, role qualification, and adherence to regulatory standards Basic Qualifications
- Bachelor's degree in a scientific, engineering, or related field
- Minimum of 5 years of experience in medical device complaint handling, MDR reporting, or regulatory compliance
- Minimum of 2 years of direct people management experience
- Strong knowledge of 21 CFR Part 803 and MDR requirements
- Experience with complaint handling systems (e.g., ETQ Reliance, TrackWise)
- Experience supporting FDA inspections and CAPA activities Preferred Qualifications
- Experience leading MDR remediation or retrospective review programs
- Familiarity with FDA eMDR submission processes
- Experience with FDA device, patient, and evaluation coding
- Knowledge of risk management and CAPA integration
- Experience building or optimizing high-volume workflows Core Competencies
- Leadership and performance management
- Audit readiness and attention to detail
- Regulatory decision-making in complex scenarios
- Process improvement and standardization
- Cross-functional communication and collaboration Work Environment / Expectations
- Fast-paced, high-volume regulatory remediation environment
- Requires strong prioritization, organization, and decision-making skills
- Ability to manage multiple workstreams and deadlines simultaneously Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide.