Assoc MDRVigilance Spec Exempt
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Job Location:
Mounds View, MN - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Job Title: Assoc MDR/Vigilance Specialist
Client: Medical Device Manufacturing Company
Duration: 2 Years (possible extension)
Location: Mounds View MN 55112 (Onsite 4 days/week)
Shift: 1st Shift
Overview:
Responsible for documenting and evaluating product feedback and analysis results to determine complaint and regulatory reporting status per FDA and OUS guidelines. Supports surveillance of medical devices and ensures timely submission of Medical Device Reports (MDRs) and Vigilance Reports (VRs).
Top Skills:
- Nursing/medical background or clinical experience with medical devices
- Biomedical Engineering or Biomedical Neuroscience education
- Pre-med or biological sciences background (Anatomy Physiology etc.)
Education & Experience:
- Bachelors degree (Science or related field)
- 0 2 years of experience in healthcare pharma or medical device industry
- Strong computer proficiency (MS Office SAP Siebel Oracle Clinical)
Key Responsibilities:
- Evaluate and document complaints to determine MDR/Vigilance eligibility
- Compile and submit regulatory reports to FDA and international agencies
- Monitor complaint activities and ensure timely closure and compliance
- Collaborate with internal teams and external partners to gather information
- Maintain awareness of regulations and product updates
- Support safety data review ADE data extraction and reporting accuracy
Preferred Qualifications:
- Degree in Nursing Biology Pre-Med or Biomedical Engineering
- Knowledge of anatomy and physiology
- Strong written and verbal communication
- Detail-oriented with high accuracy in documentation
#ZR
Key Skills
- Anti Money Laundering
- Accounting Tally
- HR Reporting
- Advertising Sales
- Infection Control
- Analytics
