Current position and relevant professional experience:
My current position is Innovation Lead for health at Innovate UK (part of UK Research & Innovation). Part of my role involves responsibility for a number of funding programs that support SMEs developing innovative health and life science projects. These include the Biomedical Catalyst, EUREKA Healthy Ageing and support for UKRI COVID-19 rapid response. The other part of my role is exploring mechanisms to support health and life science companies more broadly.
Recently, I was seconded to MHRA to support the Rapidly Manufactured Ventilator System challenge and worked closely with regulatory professionals to provide support for the various projects.
I’m currently championing investment into a network of regulatory science centres and support for companies transitioning to IVDR/MDR. Previously, I was a Group Manager at MHRA responsible for a team of 50 regulatory
professionals tasked with Safety & Surveillance of medical devices. We worked closely with
EU counterparts to manage specific issues and develop the MDR/IVDR legislation.
I’ve also had the pleasure of spending 10 years in the medical device industry, primarily in
cardiac rhythm management (Class III implantable devices) culminating in my role as Country
Director for UK & Eire at BIOTRONIK.
My passion for medical devices first started at University and led me to undertake a Ph.D. that
investigated wear & degradation of UHMWPE hip and knee prostheses.
Current or previous involvement in TOPRA activities:
I’m currently a member of the MedTech SPIN group and in my tenure at MHRA, worked with TOPRA to develop training programmes.
Personal statement:
Global response to COVID-19 pandemic has highlighted the critical role of regulation in
enabling rapid scale-up of crucial healthcare products and the acceleration of innovative
solutions.
As a result, there is increased awareness of the crucial role of regulatory affairs professionals
in enabling organizations to navigate regulatory requirements to provide patients,
populations and users with access to safe & effective products.
The future holds exciting challenges for regulatory affairs professionals with emerging areas
such as advanced mathematical algorithms, distributed manufacturing of ATMP, cognitive
enhancement etc.
TOPRA have a key role in growing, developing and supporting a skilled workforce
Nomination information
Proposer: Ivan Perez-Chamorro; Seconders: Phil Brown, Eithne Lee