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FocusKPIFO

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

FocusKPI, Inc. specializes in data analytics and AI solutions, empowering global brands to optimize ROI and improve operational efficiency.

FocusKPI

Employee count: 11-50

United States only

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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.

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United States +/- 0 hours

About FocusKPI

Learn more about FocusKPI and their company culture.

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FocusKPI, Inc., founded in 2010, is a distinguished name in the realm of data science and technology, specializing in AI, predictive analytics, and business intelligence solutions. Our commitment to enhancing productivity and optimizing return on investment (ROI) is at the core of our operations. We empower our clients to make informed decisions by providing tailored analytics solutions that cater to their unique business challenges.

Our areas of expertise encompass a wide range of services including custom marketing analytics, staffing and recruiting solutions, and enterprise AI products. We work closely with various sectors, including retail, healthcare, and e-commerce, ensuring that every solution we deliver is designed to drive efficiency and significant improvements in business operations. By leveraging advanced technologies like machine learning and data visualization, we are dedicated to helping organizations navigate the complexities of big data while achieving actionable insights. The high standards of service we uphold have earned us a reputation for excellence and trust among our clients, affirming our position as a leader in the analytics and data science landscape.

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FocusKPI

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