Job Title: Medical Device Complaint Specialist
Client: Medical Device Manufacturing Company
Location: Mounds View, MN 55112
Duration: 12 Months (Possible Extension)
Shift: 1st Shift
Job Summary
Entry-level medical device safety and complaint investigation role responsible for intake, documentation, adverse event reporting, MDR submissions, and vigilance activities for Neurovascular products while ensuring compliance with regulatory requirements.
Key Responsibilities
• Review, document, and investigate product complaints
• Process Medical Device Reports (MDRs) and adverse event cases
• Maintain accurate complaint and vigilance records
• Analyze safety and clinical data for reporting purposes
• Ensure compliance with FDA and global regulatory requirements
• Support complaint investigations and follow-up activities
• Collaborate with cross-functional teams and external partners
• Assist with process improvements and quality initiatives
• Prepare regulatory documentation and reports
Core Duties
• Complaint handling & investigation
• Medical Device Reporting (MDR)
• Adverse event processing
• Regulatory compliance support
• Safety data review & analysis
• Documentation & case management
Required Skills
• Critical thinking and decision-making
• Strong attention to detail
• Excellent written and verbal communication
• Investigation and problem-solving skills
• Documentation and record management
• Organization and time management
Preferred Skills
• Medical device industry experience
• Pharmaceutical industry experience
• Complaint handling experience
• Regulatory reporting knowledge
• Quality or compliance exposure
• Clinical data review experience
Technical / Functional Exposure
• Medical Device Reporting (MDR)
• Vigilance & Post-Market Surveillance
• Complaint Investigation
• Adverse Event Reporting (ADE)
• Regulatory Compliance
• Clinical & Safety Data Analysis
Work Environment
• Medical device regulatory and quality environment
• Cross-functional collaboration with quality, regulatory, and clinical teams
• Process-driven and compliance-focused role
• Training and development opportunities for entry-level professionals
Education / Experience
• Bachelor's Degree in Bio-Sciences, Engineering, Life Sciences, or related field required
• Experience in Medical Device, Pharmaceutical, Quality, Regulatory, Clinical, or related industry
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