Current position and relevant professional experience:
I currently serve as Founder and Partner of a Medical Device Quality and Regulatory consultancy with offices in Australia, New Zealand, and the UK, and am leading our strategic expansion into Europe alongside the creation of a MedTech Accelerator programme in the EU. Over 27 years, I have held senior regulatory leadership positions, including QA and RA Director across both IVD and medical device sectors, with product experience spanning from blood gas analysers to surgical robotics. My approach is anchored in ensuring meaningful safety and effectiveness rather than mere regulatory form-filling. I have consistently promoted risk-based compliance as a core principle, particularly in light of emerging AI challenges. I have also actively contributed to the profession through conference presentations, publications, student mentorship, and academic teaching.
Current or previous involvement in TOPRA activities:
I have been a TOPRA member since 2005 and was granted Fellowship status in 2025. I am also a Fellow of the Chartered Quality Institute. I am currently co-leader and presenter on the TOPRA MSc course, Module 19 IVD.
Personal statement:
When I reflect on what has sustained me through 27 years in medical device regulatory affairs, it comes down to one thing: the knowledge that what we do ultimately affects real patients. That sense of purpose has guided every role I have held. Each has reinforced the importance of getting regulation right and applying it pragmatically.
My consultancy now operates in Australia, New Zealand, and the UK, with European expansion planned alongside the launch of a MedTech Accelerator. This has given me a unique vantage point on how different regulatory systems approach the same challenges and how much we can learn from each other. I have also seen how risk management is often the weakest link in regulatory practice, despite being the most powerful tool we have. I have made it a priority to challenge this, encouraging both employers and clients to treat risk-based compliance as a strategic asset, particularly as AI introduces new and dynamic risk profiles.
I am known for my commitment to mentoring, teaching, and sharing knowledge through conference presentations, whitepapers, blogs, and academic lecturing and other voluntary roles. I believe that as experienced professionals, we have a duty to lift others and strengthen the community where healthcare is involved.
I would like to join the TOPRA Board because I see an organisation that can and should shape the future of our profession. With the regulatory world becoming more complex, more global, and more technologically driven, TOPRA's role in education, guidance, and advocacy has never been more important with the advent of AI where regulation is still playing catch-up. I want to contribute to that mission as an active, engaged Board member who brings practical experience, international perspective, and a steadfast commitment to patient-centred, risk based regulation.