Regulatory Affairs Specialist
Global Connect Technologies, Mundelein, IL, United States
Job Title: Complaint Specialist – MDR Remediation
Job Type:
Contract (1–2 Years, Potential for Full-Time Conversion)
Openings:
10
Job Summary
We are seeking
Complaint Specialists
to support
Medical Device Reporting (MDR) remediation activities . This role focuses on
retrospective complaint review and MDR reportability assessments
in compliance with
FDA regulations (21 CFR Part 803) .
The ideal candidate will have hands-on experience reviewing both
historical and new complaint records , applying regulatory decision logic, and ensuring accurate and compliant reporting.
Key Responsibilities
Review historical complaint files as part of remediation efforts to verify completeness and reassess MDR reportability decisions
Apply current FDA MDR regulations, definitions, and decision trees to legacy complaints
Identify missing or incomplete complaint data and collaborate with cross-functional teams (Quality, Regulatory, Operations) to gather required information
Prepare and submit MDRs through the FDA’s
electronic MDR (eMDR)
system when required
Ensure compliance with FDA Quality System Regulations, including complaint handling under
21 CFR 820.198
Support high-volume remediation projects within strict timelines
Required Qualifications
Bachelor’s degree in a relevant field
Minimum
1+ year of experience
in:
MDR evaluation
Regulated healthcare/medical device environment
Working knowledge of
FDA MDR regulations (21 CFR Part 803)
Ability to interpret medical narratives, adverse events, and product complaints
Experience handling high-volume documentation or remediation projects
Strong analytical skills and attention to detail
Preferred Qualifications
2+ years of MDR reporting or complaint remediation experience
Experience in medical device, pharmaceutical, or healthcare industries
Familiarity with complaint management systems such as:
SAP
TrackWise
Experience working in fast-paced remediation environments with strict deadlines
Strong attention to detail and accuracy
Excellent written and verbal communication skills
Ability to document clear, audit-defensible decisions
Strong analytical and critical thinking abilities
Ability to quickly learn regulatory processes and workflows
Effective time management and prioritization skills
Comfortable working in compliance-driven, structured environments
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Job Type:
Contract (1–2 Years, Potential for Full-Time Conversion)
Openings:
10
Job Summary
We are seeking
Complaint Specialists
to support
Medical Device Reporting (MDR) remediation activities . This role focuses on
retrospective complaint review and MDR reportability assessments
in compliance with
FDA regulations (21 CFR Part 803) .
The ideal candidate will have hands-on experience reviewing both
historical and new complaint records , applying regulatory decision logic, and ensuring accurate and compliant reporting.
Key Responsibilities
Review historical complaint files as part of remediation efforts to verify completeness and reassess MDR reportability decisions
Apply current FDA MDR regulations, definitions, and decision trees to legacy complaints
Identify missing or incomplete complaint data and collaborate with cross-functional teams (Quality, Regulatory, Operations) to gather required information
Prepare and submit MDRs through the FDA’s
electronic MDR (eMDR)
system when required
Ensure compliance with FDA Quality System Regulations, including complaint handling under
21 CFR 820.198
Support high-volume remediation projects within strict timelines
Required Qualifications
Bachelor’s degree in a relevant field
Minimum
1+ year of experience
in:
MDR evaluation
Regulated healthcare/medical device environment
Working knowledge of
FDA MDR regulations (21 CFR Part 803)
Ability to interpret medical narratives, adverse events, and product complaints
Experience handling high-volume documentation or remediation projects
Strong analytical skills and attention to detail
Preferred Qualifications
2+ years of MDR reporting or complaint remediation experience
Experience in medical device, pharmaceutical, or healthcare industries
Familiarity with complaint management systems such as:
SAP
TrackWise
Experience working in fast-paced remediation environments with strict deadlines
Strong attention to detail and accuracy
Excellent written and verbal communication skills
Ability to document clear, audit-defensible decisions
Strong analytical and critical thinking abilities
Ability to quickly learn regulatory processes and workflows
Effective time management and prioritization skills
Comfortable working in compliance-driven, structured environments
#J-18808-Ljbffr