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.

What You’ll Do

• 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

Time Commitment

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

Preferred Background

• 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.

How to Apply

If you’re interested, please complete this short screening form so we can better understand your background:

We’ll follow up with selected candidates to schedule an initial session and discuss next steps.

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