Amy Hoffmann

About Amy Hoffmann

I’m a seasoned scientific leader with over two decades of experience in the medical device industry. My career has been built on a deep foundation of technical expertise in biological safety, FDA and EU MDR regulations, and global compliance standards. I thrive at the intersection of science and strategy—leading high-performing teams, mentoring future leaders, and ensuring regulatory excellence across complex projects.Throughout my roles at NAMSA, I’ve scaled teams, led global process improvement initiatives, and partnered closely with clients and cross-functional stakeholders to navigate evolving international regulatory landscapes. Whether it\'s developing strategic responses for FDA or EU submissions, enhancing technical operations, or speaking at international conferences, I bring clarity, rigor, and collaboration to everything I do.I’m passionate about building careers, not just teams—and I believe in empowering others through mentorship, training, and thoughtful performance management.Let’s connect if you’re interested in medical device regulatory strategy, biological safety, or growing strong scientific teams that deliver real-world impact.

Experience

1. Consultant

   Project Medtech

   Jul 2025 — Present

Education

• University of Cincinnati

  BS, Biochemistry

  1994 — 1999

Skills

• Design Control
• Glp
• Product Development
• Regulatory Affairs
• Lifesciences
• R&D
• Validation
• Pharmaceutical Industry
• Fda
• Biotechnology
• Research and Development (R&D)
• Medical Devices
• Capa
• Iso 13485
• Gmp