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Job Title


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


Company : FocusKPI Inc.


Location : Boston, MA


Created : 2026-04-04


Job Type : Full Time


Job 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 Youu2019ll 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 30u201345 minute feedback sessions Time Commitment + Flexible, ongoing engagement + Approximately 1u20132 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 youu2019re interested, please complete this short screening form so we can better understand your background: Weu2019ll 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 @ email domain. If you have received fraudulent emails now or in the past, please report it to . The domain @ is fraudulent and not related to FocusKPI. Please do not not reply or communicate to anyone with @. Powered by JazzHR