I’m frequently presented with interesting challenges and no two days are ever the same. I find it to be very fulfilling as I have the opportunity to really help engineer better health.
Jacqueline Beddoe-Rosendo, Design Quality and Regulatory Lead – Medical Devices
10 June 2024
In Conversation with Jacqueline Beddoe-Rosendo
Jackie is the Design Quality and Regulatory Lead of the Medical Engineering Quality Management System at King's. We spoke to her about how her role acts as a bridge between engineering, law and healthcare, and why quality and regulation management is essential to engineering better health.
Jackie began her journey into MedTech with an integrated Master's degree in Biomedical Engineering, followed by an MBA that focused on the innovation of medical devices.
Speaking about her professional life so far, she observes, "I was lucky to have great mentors when I started to work for medical device companies in the radiotherapy sector. I was working in the Netherlands when I came across the role of Senior Quality and Regulatory Engineer at King’s, and thought it presented a unique opportunity to work with cutting-edge technology and help bring it closer to the patients that need it."
According to Jackie, a lack of understanding of regulations is one of the leading barriers to clinical and commercial translation. She now works as one of the Leads for the Medical Engineering Quality Management System (QMS) at the London Institute for Healthcare Engineering (LIHE). "I work with my wonderful team to provide training and guidance on quality management practices and medical device regulations to researchers and early-stage innovators. This includes giving regulatory advice, helping to develop regulatory strategies, supporting risk management, and supervising the completion of required documentation for regulatory submissions."
When asked what prompted her to work in the field, she revealed that she has always been an engineer at heart. "I was 10 years old when I installed the electric cooker at home – with supervision of course!"
But she also had a sustained interest in healthcare, so working on medical devices ended up being the perfect fit. Jackie sees quality management and regulatory affairs as being a bridge between engineering, clinical practice and the law.
Jackie joined King's 4 years ago and has since contributed heavily to bringing the QMS at LIHE to life. "From a blank slate, we now have a system that is up and running and has been used by over 70 people. We are also in the process of obtaining ISO 13485 certification which will be a great milestone, and two of the projects we have worked with are spinning out from King’s this year."
One of her highlights at King's was running a seminar series, which offered comprehensive insight into quality management systems, regulations, risk management and more for researchers looking to further their technologies along the translational pathway. "Two of the projects that used our service talked about their experience working with the team and it was great to hear how they benefited from our support. I’m sure there will be plenty more highlights to come, and for now, I am looking forward to supporting the next generation of medical device innovators through LIHE’s MedTech Accelerator programme and Venture Builder."
The Medical Engineering Quality Team at LIHE offers bespoke quality and regulatory support to innovators to help them plan their regulatory strategy and meet regulatory requirements. The team runs fortnightly quality and regulatory advice drop-in sessions that can be accessed by anyone based at King’s and King's Health Partners.
Reach out to the QMS team with questions or for support at cme-quality@kcl.ac.uk.
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Design Quality and Regulatory Lead