Supervisor - MDR Remediation (5 Roles Total)

A client of ours is looking to hire a number of Data Clerk/Data Analysts as well as a handful of supervisors for a large MDR Remediation project. They are looking for 4-5 supervisors to start with and then an additional 40-60 data clerks. The deadline for them to have all the data uploaded to the FDA is October 20^th. To do this they need reliable people. They will have 40 hours of work each week with 3 days being onsite with 2 days remote. Each supervisor will be leading a team of 20-25.
They will interview for the supervisor roles but will have a go to work situation for the data entry positions. This is a great resume builder for anybody looking to start their career but also fine for people who are still in college and home for the summer. They understand that if they are still in college they will have to end their contract earlier. Not an issue. The main requirements are they are capable, strong with basic computer skills, can pass a drug and background check.

Below are the descriptions for the supervisor and data analyst roles.

Supervisor, MDR Remediation (FDA 483 Response)
Job Description Summary
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 and SOP-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 stands at the forefront of Talent + Technology solutions with a presence spanning more than 70 locations worldwide and a team exceeding 10,000 professionals. As one of the largest technology and professional staffing companies and one of the largest minority-owned staffing companies in the United States, Dexian combines over 30 years of industry expertise with cutting-edge technologies to deliver comprehensive global services and support.

Dexian connects the right talent and the right technology with the right organizations to deliver trajectory-changing results that help everyone achieve their ambitions and goals.To learn more, please visit https://dexian.com/.

Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.