Job Title: ย ย ย ย ย ย ย Medical Device Complaint Specialist
Client: ย ย ย ย ย ย ย ย ย ย ย ย Medical Device Manufacturing Company
Location: ย ย ย ย ย ย ย Mounds View, MN 55112
Duration: ย ย ย ย ย ย ย 24 Months (Possible Extension)
Shift: ย ย ย ย ย ย ย ย ย ย ย ย ย ย 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
- Bachelorโs degree (Biology, Nursing, Biomedical, Pre-med/Pre-vet preferred)
- 0โ2 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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