Medical Device Risk Management Advisor (Part-Time, Remote)

FocusKPI Inc. • Boston, MA

9d • Remote

About The Position

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.

Requirements

• Medical device regulatory affairs or quality assurance
• Experience with ISO 14971 risk management
• Design controls / DHF documentation
• Risk management file, FMEA, or hazard analysis experience

Nice To Haves

• 510(k), De Novo, or PMA experience is a plus
• Consultants and industry professionals are welcome.

Responsibilities

• 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

What This Job Offers

• Job Type: Part-time
• Career Level: Mid Level
• Education Level: No Education Listed