From surgeon to regulatory strategist
I help medical device manufacturers build strong, defensible clinical evidence under MDR. My background as a medical doctor gives me the clinical perspective that makes regulatory documentation credible and reviewer-friendly. Today, I work with Start-ups and global MedTech companies to ensure their devices meet compliance requirements without unnecessary complexity.
Why I switched from surgery to regulatory
Many people reach out to ask how I became a regulatory writer, so I thought it was time to share my story.
I began my career as an orthopedic and trauma surgeon, working in hospitals for several years. Over time, I realized that the clinical environment was not where I wanted to spend the rest of my professional life.
At first, I had no clear idea of what to do next. Like many physicians considering a change, I questioned whether there was even a viable alternative career path for me. Early conversations with recruiting firms were often discouraging. After some time, I joined an international MedTech company as a medical writer — and I immediately knew I had found my place.
Today, I lead my own regulatory consulting business, collaborating with various companies: from innovative startups and small to mid-sized enterprises (KMUs) to large international corporations. I support them in ensuring the regulatory compliance of their medical devices.
In addition to my consulting work, I conduct workshops and training sessions to help teams understand regulatory requirements and establish clear templates and processes.
Running my own business has been one of the most rewarding decisions I’ve ever made. I value the diversity of my projects, the inspiring people I work with, and the opportunity to learn and grow every day.
Clinical knowledge across various device categories
Here is a snapshot of different areas I have been working with. My work as a medical doctor allowed me to gain experience in orthopedics, trauma surgery, spine surgery, and intensive care medicine. I am a Certified Professional for Medical Software and always interested in the latest developments in this area.
I also wrote several clinical evaluations for cardiovascular or aesthetic medical devices. You can't find the medical condition relevant for your device here? Then send me a message and we can figure out if how I can support your projects.
Schedule a free session to see how we can address your regulatory challenges together.
Trusted by leading brands
Active in the Medical Writing community
As a regulatory consultant, it is essential for me to constantly expand my knowledge and exchange ideas with other medical writers. I am an active member of the Special Interest Group for Medical Devices and regularly provide trainings on regulatory topics at international conferences. For the journal "Medical Writing", I contributed articles on regulatory topics, such as the Summary of Safety and Clinical Performance for Medical Devices, PMCF, and real-world evidence.
