[Hiring] Medical Device Risk Management Advisor @FocusKPI

Role Description

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

Qualifications

• 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: Application Form

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

NOTICE

Please be aware of fraudulent emails regarding job postings, job offers and fake checks. FocusKPI's recruiting team will strictly reach out via @focuskpi.com email domain. If you have received fraudulent emails now or in the past, please report it to FTC Fraud Reporting .

The domain @focuskpijobs.com is fraudulent and not related to FocusKPI. Please do not reply or communicate to anyone with @focuskpijobs.com.