The Story of My FDA Career

I spent 36 years at the FDA, and while I rose to top leadership roles, I always believed the best way to get things done was by being a real person within a massive bureaucracy.

In my final few years, I served as Deputy Program Director and Operations Staff Director for the Office of Medical Device and Radiological Health Operations within the agency’s inspection operations. I managed daily strategy, compliance, and high-stakes inspections worldwide. At this level, I lead the development of national policy, which required a practical mindset, rather than a rigid reliance on regulations.

The executive-level work was built on over two decades in the FDA's Minneapolis office, leading field operations. Knowing the reality of the ground-level work made me the go-to bridge to agency headquarters. My job was to translate complex federal rules into clear, real-world strategies and to execute regulatory enforcement that protected public health without stifling medical innovation.

It all started as a field investigator in Portland, Oregon, where I always volunteered for complex and unusual cases. Once I realized that I belonged in medical devices, I returned home to Minnesota to immerse myself in the industry's “Medical Alley”. That hands-on experience gave me a deep understanding of the practical challenges companies face.

After more than three and a half decades of public service, I stepped away in 2025.