Christie Johnson

About Christie Johnson

I think about failure modes for fun. I lose sleep over edge cases. The smartest medtech teams put risk at the center of product development not because they have to but because it makes everything better.I work with startups to build Risk Management Files that reflect how their devices actually work and fail. ISO 14971:2019 is my native language, but I translate it into tools that teams can actually use. We start early, iterate often, and bake safety and clarity into every decision. I also help teams tackle clinical trials and regulatory strategy - making sure the plans and documents reflect real-world use and are built to get devices to market, fast.I’m equally obsessed with AI. Not just the shiny stuff but the hard questions. How can we build AI tools that make complex work like risk management, regulatory, and clinical operations easier, smarter, and more scalable? How can we help startups do more with less?If you’re building something that matters, message me. I want to help you build it right.

Experience

1. Vice President of Quality and Regulatory

   Mybiometry

   Apr 2021 — Present · Boston, MA, US

   myBiometry is focused on one of the biggest healthcare problems in the world, asthma. Our mission is to help asthma patients prevent symptoms and attacks. Our solution combines digital health, patented sensor and device technology, machine learning, and clinical oversight to turn biomarker data into actionable insights.

Education

• Purdue University

  B.S, Mechanical Engineering

• Emergency Medical Technician

  Certificate

Skills

• Minitab
• Matlab
• Medical Devices
• Solidworks