How did you get into regulatory affairs?
After leaving college my first job was at the Surgical Materials Testing Laboratory in Wales where, like many technicians/scientists, I was mainly on my feet all day, testing medical devices for safety and performance and finding out why they failed in use. When the Medical Devices Directive was first published in 1993, I was using this in my work and gained a good working knowledge and experience in the application of the requirements within it.
In 2001 I obtained an entry level medical device specialist role at the Medicines and Healthcare Products Regulatory Agency (MHRA) and my experience was accepted as a credible alternative to a degree, which I do not hold. I felt this was a great opportunity to continue my career in the field of medical devices. So I moved to London – trading the M4 for the M25.
While working for the Devices division at the MHRA I advanced my career; diversifying in my role and responsibilities and ensuring I continued to develop my personal and professional skills to meet the demands of the role.
Ensuring the safety and performance of medical devices has been my sole career path for over 25 years. I have been privileged to work with great people who are passionate about the work they do and the difference we make to protect public health. With the changes to the Medial Device Regulations and the impact of Brexit there are new opportunities for us all.
What is your current role/area of work?
I am currently on secondment from the Devices into Human Resources division: as Careers Pathway Lead for the MHRA, to deliver on an agency-wide initiative to support our people in achieving their career goals. I get to work with a wide range of people across the agency, who are at different levels in their careers.
My substantive role is as one of six Team Managers in the Devices Safety and Surveillance division. We’re responsible for guiding and supporting its people to ensure the safety and performance of medical devices, and adding value through strategic thinking. As a team, we monitor adverse event investigations, give advice, identify potential breaches in the regulations, assess clinical investigations and work with manufacturers and other regulatory bodies to bring them back into compliance, using a risk-benefit approach to decision making.
I believe my secondment will help people across the agency achieve their goals and increase the pool of talented and skilled people in regulatory affairs.
What challenges/opportunities did you face advancing up the career ladder?
I don’t have a degree, but this has never held me back and I feel quite proud of the experience and knowledge that I have brought to the MHRA. Having said that, becoming a senior manager and member of the senior team brings its own challenges and new skills to develop. Continuous learning is key, and the MHRA invests in its staff to ensure we have the right skills to do our jobs. So, I have developed my leadership and management skills through various courses and gained a Chartered Management qualification to ensure I am an effective manager.
Working for the MHRA I have sought and created several development opportunities, sometimes having to expand my depth and breadth of expertise across a range of different devices to meet business needs, which has resulted in several promotions. I feel it is important to keep challenging oneself, so whilst my secondment as Career Pathway Lead is a horizontal move, it was very much outside of my comfort zone of devices. But now I relish the challenges it brings, the new and range of skills I am developing and working with a diverse group of people to achieve our objectives.
What does diversity mean to you as a manager and regulatory affairs professional?
At the MHRA we promote a culture that actively values differences and recognises people from different backgrounds and experiences can bring invaluable insights to the agency and how we work. I believe in adopting a multi-disciplinary approach to get things done and solving problems. As managers we must advance equality of opportunities between people, building relationships along the way to gain an understanding and mutual respect of others.
What tips do you have for other TOPRA members about utilising diversity to improve business performance? How can focusing on diversity impact business outcomes?
- Be inclusive rather than exclusive.
- Give people opportunities that may be outside of their comfort zone.
- Build a rapport with people to get the best out of them.
- Treat everyone as individuals and respect differences.
Finally; I have a bit of a track record for using the following quote in team projects, but it typifies why diversity is important to getting things done in a collaborative way:
"The best way to have good ideas is to have a lot of ideas." – Linus Pauling