| Location | Mounds View, MN |
| Job Type | Contractor |
| Salary | $25–$30 Per Hour |
Job Title: Associate MDR/Vigilance Specialist
Client: Medical Device Manufacturing Company
Location: Mounds View, MN 55112
Duration: 2 Years + Possible Extension
Shift: 1st Shift | Onsite
Description:
Job Summary
Support Medical Device Reporting (MDR), complaint handling, adverse event reporting, and medical device surveillance activities while ensuring regulatory and quality compliance.
Key Responsibilities
· Process and review MDR complaint records.
· Support complaint handling and medical device surveillance.
· Manage adverse event report intake, evaluation, processing, and follow-up.
· Maintain accurate MDR and ADE records.
· Review clinical databases and analyze safety data.
· Prepare safety summaries and regulatory reports.
· Ensure compliance with regulatory requirements and quality procedures.
· Support regulatory reporting programs and processes.
· Collaborate with internal teams and stakeholders.
· Complete assigned projects and maintain accurate documentation.
Required Skills
· Medical Device Reporting (MDR)
· Complaint Handling
· Regulatory Compliance
· Medical Device Surveillance
· Adverse Event / ADE Reporting
· Clinical Database Review
· Safety Data Management
· Data Analysis & Documentation
· Strong Critical Thinking
· Excellent Organization & Time Management
· Cross-functional Collaboration
Top Hiring Needs
· Previous MDR experience
· Excellent organizational and time-management skills
· Strong critical-thinking skills
Qualifications
· Bachelor's Degree required
· 1–3 years of relevant experience
· Medical device or regulated-industry experience preferred
· Clinical background (RN/healthcare professional) preferred
· Biomedical Engineering background is a strong plus
· Understanding of quality systems and regulatory requirements
Role Level
· Entry-level individual contributor
· Works under close supervision
· Handles routine/less-complex projects
· Supports process improvements and regulatory activities
Medical Device Manufacturing Company