Medical Device Complaint Specialist
Three Point Solutions, Mounds View, MN, United States
Job Description
Job Title:
Medical Device Complaint Specialist
Client:
Medical Device Manufacturing Company
Location:
Mounds View, MN 55112
Duration:
24 Months (Possible Extension)
Shift:
1st Shift
Job Summary
Supports medical device safety and regulatory compliance by evaluating product complaints, determining reporting requirements, and ensuring accurate submission of regulatory reports (MDR/Vigilance).
Key Responsibilities
Review product complaints and determine regulatory reporting eligibility
Prepare and submit Medical Device Reports (MDRs) and Vigilance Reports
Monitor complaint lifecycle to ensure timely closure
Collaborate with internal teams for data collection and investigation
Core Duties
Evaluate adverse event data and product feedback
Analyze clinical and product data for safety reporting
Maintain compliance with FDA and global (OUS) regulations
Support complaint investigations and follow‑ups
Ensure accuracy and completeness of regulatory documentation
Act as liaison across teams for compliance and reporting processes
Required Qualifications
Bachelor’s degree (Biology, Nursing, Biomedical, Pre‑med/Pre‑vet preferred)
0–2 years experience (entry‑level acceptable)
Strong understanding of anatomy/physiology (academic is fine)
High attention to detail and analytical thinking
Proficiency in MS Office and data systems (SAP, Oracle, etc.)
Preferred Qualifications
Clinical or medical device exposure
Strong written and verbal communication skills
Experience in safety, clinical data, or regulatory environments
Key Skills
Regulatory compliance & documentation
Data analysis & interpretation
Attention to detail (critical for reporting accuracy)
Cross‑functional coordination
Problem identification & resolution
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Job Title:
Medical Device Complaint Specialist
Client:
Medical Device Manufacturing Company
Location:
Mounds View, MN 55112
Duration:
24 Months (Possible Extension)
Shift:
1st Shift
Job Summary
Supports medical device safety and regulatory compliance by evaluating product complaints, determining reporting requirements, and ensuring accurate submission of regulatory reports (MDR/Vigilance).
Key Responsibilities
Review product complaints and determine regulatory reporting eligibility
Prepare and submit Medical Device Reports (MDRs) and Vigilance Reports
Monitor complaint lifecycle to ensure timely closure
Collaborate with internal teams for data collection and investigation
Core Duties
Evaluate adverse event data and product feedback
Analyze clinical and product data for safety reporting
Maintain compliance with FDA and global (OUS) regulations
Support complaint investigations and follow‑ups
Ensure accuracy and completeness of regulatory documentation
Act as liaison across teams for compliance and reporting processes
Required Qualifications
Bachelor’s degree (Biology, Nursing, Biomedical, Pre‑med/Pre‑vet preferred)
0–2 years experience (entry‑level acceptable)
Strong understanding of anatomy/physiology (academic is fine)
High attention to detail and analytical thinking
Proficiency in MS Office and data systems (SAP, Oracle, etc.)
Preferred Qualifications
Clinical or medical device exposure
Strong written and verbal communication skills
Experience in safety, clinical data, or regulatory environments
Key Skills
Regulatory compliance & documentation
Data analysis & interpretation
Attention to detail (critical for reporting accuracy)
Cross‑functional coordination
Problem identification & resolution
#J-18808-Ljbffr