Job Title: Medical Device Complaint Specialist
Client: Medical Device Manufacturing Company
Duration: 2 Years (Possible Extension)
Location: Mounds View, MN 55112
Shift: 1st Shift
Key Responsibilities
- Review and evaluate product complaints and adverse event reports.
- Determine Medical Device Reporting (MDR) and Vigilance reporting eligibility.
- Prepare and submit MDR, Vigilance Reports (VR), and Adverse Drug Experience (ADE) reports.
- Monitor complaint investigations through closure and ensure timely follow-up.
- Review product analysis and investigation results.
- Ensure compliance with FDA and international (OUS) regulatory requirements.
- Maintain complaint documentation and regulatory records.
- Analyze clinical and safety data for regulatory reporting.
- Collaborate with internal teams and external partners to collect complaint information.
- Support medical device surveillance and post-market vigilance activities.
- Maintain knowledge of new products, regulations, and reporting requirements.
- Support continuous improvement of complaint handling and regulatory reporting processes.
Must-Have Requirements
- Bachelor's Degree in a Science-related field.
- 1–2 years of experience in Healthcare, Medical Device, Pharmaceutical, Safety, or Clinical Data Evaluation.
- Strong computer skills (Microsoft Office, SAP, Siebel, Oracle Clinical, or similar systems).
- Knowledge of complaint handling and adverse event documentation.
- Strong analytical and problem-solving skills.
- Excellent written and verbal communication skills.
- High attention to detail.
- Ability to work with regulatory documentation and confidential information.
Preferred Qualifications
- Degree in Nursing, Biology, Pre-Med, Pre-Vet, Biomedical Engineering, or Biomedical Sciences.
- Clinical or nursing background.
- Medical Device industry experience.
- Knowledge of FDA Medical Device Reporting (MDR) requirements.
- Knowledge of anatomy and physiology.
- Experience with complaint investigations and post-market surveillance.
- Experience with regulatory reporting systems.
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