About the roleWe 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 DoTest new features and prototypes periodicallyProvide feedback on usability and regulatory alignmentReview risk management and documentation workflowsSuggest improvements based on real industry practiceJoin occasional 30–45 minute feedback sessionsTime CommitmentFlexible, ongoing engagementApproximately 1–2 hours per week or biweeklyFully remotePreferred BackgroundMedical device regulatory affairs or quality assuranceExperience with ISO 14971 risk managementDesign controls / DHF documentation510(k), De Novo, or PMA experience is a plusRisk management file, FMEA, or hazard analysis experienceConsultants and industry professionals are welcome.How to ApplyIf 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.

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

Emma

Requirements and responsibilities

Skills wanted:

Language(s) required:

Peter Zhu

About FocusKPI Inc.:

focuskpi.com

Admin access needed

Payment confirmed

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