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: https://forms.gle/jgj1ZN2jtAGGAbYQA 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 https://reportfraud.ftc.gov/ . The domain @focuskpijobs.com is fraudulent and not related to FocusKPI. Please do not not reply or communicate to anyone with @focuskpijobs.com.