My journey began with a simple question: How does scientific discovery become something tangible that improves patients’ lives?
I’ve always been fascinated by the intersection of research and real-world impact, where raw data becomes a tool to diagnose, treat, and heal. For me, Regulatory affairs turned out to be the perfect bridge between these worlds, helping to transform innovation into accessible, safe medical advances.
First Steps: Standards, Science, and Global Impact
During my time at university, I undertook a placement year at the National Institute for Biological Standards and Control (NIBSC), a centre of the MHRA. I worked with WHO International Standards for blood coagulation factors - the highest level of reference materials for estimating and measuring these biological components.
This was my introduction to in vitro diagnostics and the invisible framework that ensures accuracy in labs worldwide. I saw how these standards play a crucial role in not only ensuring the accuracy and consistency of diagnostic tests used around the world, but also for manufacturers producing therapeutic products, reagents, and diagnostic kits, ensuring consistency across borders. More importantly, I glimpsed the regulatory ecosystem that safeguards patient safety while fostering innovation.
This experience sparked my interest in regulatory affairs, a field at the intersection of science, law, and business, all working together to protect public health.
From Theory to Practice: Joining Mantra Systems
After graduating, I knew I wanted to be part of this dynamic field. That led me to Mantra Systems, a consultancy specialising in medical device regulatory affairs. Here, I’ve had the privilege of working with manufacturers at every stage, from startups navigating their first CE mark to global companies adapting to the MDR and IVDR.
One of the most surprising lessons? The sheer variety of products that qualify as medical devices under the regulations, some of which I’d never have initially considered. From reading glasses and surgical gloves to breath analysers and AI-powered software, the diversity of technologies is incredible. It’s fascinating to see how even everyday items can be considered a medical device depending on their intended purpose. Working across such a broad spectrum of products keeps the job intellectually stimulating and ensures no two projects are ever the same.
Why Regulatory Affairs Matters
What excites me most about this work is its dual impact: it’s intellectually rigorous and deeply purposeful. Yes, the regulatory landscape is complex (especially with transitions like MDD to MDR and IVDD to IVDR). But that complexity drives constant learning and growth.
Whether I’m drafting a Clinical Evaluation Report or conducting a risk analysis, I know my work helps bring safer, faster, and smarter medical devices to market. That’s the heart of regulatory affairs: protecting patients while empowering progress.
One of my first projects at Mantra Systems involved guiding a client through the EU MDR requirements for a software as a medical device. They had clinically impactful technology but were overwhelmed by regulatory uncertainty. Together, we transformed their confusion into a clear, actionable roadmap - aligning their evidence with MDR expectations and guiding them through each step of the CE marking journey.
Looking back, what began as a placement year at university has evolved into a deeply fulfilling career at the intersection of innovation and public health. I’m grateful to be part of a field where my scientific background can make a real-world impact, helping ensure that life-changing medical technologies reach those who need them, safely and effectively. As I continue this journey, I’m excited to keep learning and growing with Mantra Systems.
