Meet Your Guide
Karen
Managing Director & Principal Consultant
As Managing Director and Principal Consultant at Regs by Karen Ltd, I bring over 25 years of experience in Regulatory Affairs and Quality Assurance for medical devices. In recent years, my expertise has also expanded into cosmetics, general consumer products, and food supplements.
With a degree in Applied and Human Biology, my career began in Phase I drug research before moving into the medical device sector, initially managing device clinical trials and subsequently transitioning into Regulatory and Quality roles. Having worked both within industry for manufacturers and as a consultant, I understand first-hand the practical challenges businesses face and provide clear, pragmatic solutions.
Driven by a scientific mindset and a genuine curiosity for how and why things work, every project is approached with a balance of technical precision and real-world insight. Through Regs by Karen Ltd, I deliver clear support in a complex world — helping clients navigate regulation with confidence and clarity.
Why Choose Regs by Karen?
Passionate about innovation for patients
In the world of medical devices and cosmetics, the people who ultimately benefit from these products can feel distant from the regulatory process. But to me, they are the reason it matters. Getting compliance right doesn’t just protect patients — it enables them to access exceptional, well-designed products with confidence.
I’ve had the joy of working with incredibly talented innovators whose ideas change lives. Many simply need support navigating a complex regulatory landscape, and helping them do that is the part of my work I love most.
Regs by Karen Ltd was founded with one aim: to make a difference, one product and one patient/customer at a time.