FocusKPI, Inc.

Medical Device Risk Management Advisor

FocusKPI, Inc.

part-time

Posted on:

Location Type: Remote

Location: United States

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About the role

  • 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

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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
ISO 14971risk managementdesign controlsDHF documentation510(k)De NovoPMAFMEAhazard analysis
Soft Skills
feedbackusability assessmentregulatory alignmentsuggesting improvements