Quality and Regulatory Manager
Describe your role at Sonrai
I work within the operations team, I am responsible for implementing a medical device standard Quality Management System for the business and for the IVD medical devices we are developing. Implementing a QMS involves working with different teams across the business to ensure we have processes that meet our regulatory obligations but also meet our business needs and reflect how our staff want to work. We are implementing some processes with a more agile mindset and using tools already in use throughout the business, where traditional medical device processes could be clunky and paperwork heavy.
I am also part of the IVD medical device project team, and look after the regulatory aspects, I look at the regulatory requirements our products are required to comply with. This is a really exciting time to work with our Machine Learning IVD medical devices because there are changes to general IVD legislation in the EU and UK, and there is a lot going on with AI/ML-specific product standards, guidance and information coming from industry.
Luckily, the team at Sonrai are similarly minded to me and love to know what is going on in the industry to ensure we are always making the most up-to-date decisions about our products.
What is something people in your industry/niche have to deal with that you want to fix?
Breaking the very traditional mindset that a QMS is painful to work in, causes more work and that a quality team are there to find the problems. A well-established QMS should be a tool to help a business work well, to deliver a safe and effective product and a great service to customers.
In my opinion, it is really great to see so much emphasis being placed on collecting data about medical devices in the post-market process. Proper analysis of such data will really help companies see where actions need to be taken and where potential improvements exist in their devices but also customer service.
I feel very lucky that there is a great group of Engineers and Data Scientists who will be key in helping to establish the data points we want to monitor and develop systems for analysis.
What excites you about your role at Sonrai?
The amount of possibility and openness – I’ve been with Sonrai for a year now and from the very beginning, it has been clear how open management has been to everybody raising suggestions for ways to work, products and improvements.
Some of Sonrai’s staff haven’t worked in a regulated QMS before, and I’ve been so happy to see people willing to ask questions to ensure they understand the ‘why’ we are implementing a process and also suggesting ideas for how they could be made better.
What makes working at Sonrai different from places you’ve worked before?
Similar answer to the above, I’ve worked in scaling and multinational medical device companies in the past and at times there can be a bit of reluctance to change. Don’t get me wrong, I think there was a bit of trepidation about Sonrai gaining a Quality and Regulatory Manager, but the openness to change has been really great.
I also love working in a smaller business because you can become involved in many aspects of the business. Since starting with Sonrai I’ve also become heavily involved in Data Security and Diversity, Equity and Inclusion, I knew of these before joining Sonrai but they were always very much so managed by other teams.
What did you do before joining Sonrai?
Since graduating, I’ve always worked in quality and regulatory in biopharma, IVDs and medical devices. My previous role I was managing the regulatory team and was a technical lead for a project to transition the business to EU MDR for Class III medical devices. I really loved that job and the team, and it was a hard decision to leave for Sonrai, but I am really glad I did as it has opened up a whole new world of learning.
What are the values that drive you?
Integrity is very important to me, and I think is especially important when working with medical devices. Our products will be part of a diagnostic workflow and the results could impact a patient’s treatment so being sure we are correctly defining what we are designing, how we are designing and testing it to be sure does what it says on the tin.
I am also a quietly determined person, when I have a plan and goal in mind, I will keep pushing towards that. Adaptability is coupled with that determination because one has to be able to react appropriately to change and assess what impact that change could have on the goal or plan.
What do you enjoy doing when you are not working?
I absolutely love being outside when I’m not working, that could be out doing bits in the garden, walking in the hills, mountains and forests around Belfast or just taking my dog for a walk.