FocusKPI, Inc.
FocusKPI is a data science and technology firm specializing in predictive analytics practice and methodologies.
Medical Device Risk Management Advisor
Location
United States
Posted
26 days ago
Salary
Not specified
English
Job Description
• Test new features and prototypes periodically
• Provide feedback on usability and regulatory alignment
• Review risk management and documentation workflows
• Suggest improvements based on real industry practice
• Join occasional 30–45 minute feedback sessions
Job Requirements
- Medical device regulatory affairs or quality assurance
- Experience with ISO 14971 risk management
- Design controls / DHF documentation
- 510(k), De Novo, or PMA experience is a plus
- Risk management file, FMEA, or hazard analysis experience
Benefits
- Flexible, part-time opportunity
- Consultants and industry professionals are welcome
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