Medical Equipment, Biology, Adverse Events, Analysis Skills, Clinical Data, Continuous Improvement, Cross-Functional, Documentation, FDA Requirements, Maintain Compliance, Medical Office Administration, Pharmacovigilance, Process Improvement, Product Reviews, Regulations, Regulatory Reports, Regulatory Requirements, Surveillance,
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.
- Knowledge of FDA Medical Device Reporting (MDR) requirements.
- 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.
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.
Support medical device complaint handling and post-market surveillance by reviewing product complaints, evaluating adverse events, and determining regulatory reporting requirements. Prepare and submit MDR, Vigilance, and ADE reports while ensuring compliance with FDA and international regulations. Analyze investigation and clinical safety data, maintain accurate regulatory documentation, collaborate with cross-functional teams, and drive continuous improvement in complaint management and regulatory reporting processes.
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Three Point Solutions, Inc.
At Three Point Solutions, we are committed to the highest caliber of service that will benefit our clients, candidates and employees. Unlike large, corporate style recruiting firms, we commit to individualized attention that uniquely positions us to bridge the communication gap between recruiter, employer and candidate. Our goal is to cultivate and maintain true partnerships with our clients and candidates.
LAKE SHORE, Minnesota, US
Staffing/Employment Agencies