Medical Device Risk Management Advisor; Part-Time, Remote

We are building an AI-powered platform to support medical device risk management and regulatory documentation (including ISO 14971 and design controls), and are looking for a few professionals to serve as ongoing product feedback advisors.

This is a flexible, part-time opportunity for experienced professionals who can periodically test new features, review workflows, and provide practical feedback based on real-world medical device and regulatory experience. Your input will directly shape how the product supports day-to-day work in regulated environments.

• 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

• Flexible, ongoing engagement
• Approximately 1–2 hours per week or biweekly
• Fully remote

• 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

Consultants and industry professionals are welcome.

If you’re interested, please complete this short screening form so we can better understand your background:
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We’ll follow up with selected candidates to schedule an initial session and discuss next steps.

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