Meet Caroline Timberlake
Where are you from?
I’m originally from Nottingham, but now based in Warwickshire
What did you want to be when you grew up?
A professional horse-rider.
So how did you find your way into Medical Device Regulatory?
By accident really, after university I wasn’t sure what I wanted to do, only that I wanted a technical job, which didn’t involve lab work. I found a job as a QA Officer and with the support of a great team and manager I learned the ropes quickly. Since then, I’ve been lucky to have some great progression opportunities in the companies I’ve worked for in different QA and RA roles.
Why does QA/RA interest you?
Medical devices can have a huge impact on people’s lives. QA/RA helps to ensure that those devices are safe, but also support businesses in bringing compliant devices to market in the right way.
What about your career so far?
I did a degree in Biochemistry, as I didn’t know which career path to take. After graduating, I did 9 years working my way up from QA Officer to Principal Compliance Officer for a large medical device and pharmaceutical company. From here I moved into regulatory at Summit Medical, looking after and improving their quality management system and project managing their MDR implementation project.
And your most recent work?
I’ve been Head of RA, responsible for the Quality and Regulatory teams at Summit Medical for almost 4 years.
What appealed to you about this consulting role and IMed?
I’m ready to get involved with different devices and want to help a variety of companies with their regulatory challenges. The IMed Team were so welcoming when I met them and made me realise that I can still be part of a great team, whilst continuing to use and grow my regulatory knowledge as a consultant.
What would you say are the key regulatory challenges for Med Dev companies currently?
Getting certified to MDR in time! Manufacturers need to be ready to submit MDR compliant technical documentation for scrutiny well in advance, in some cases, of their MDD CE certificate expiry whilst guidance is still being published. IVD companies must really learn the lessons and get well ahead of their IVDR deadlines. You can never start too early.
And when you’re not delving into regulatory detail, where can we find you?
You’ll find me somewhere in the countryside, with my family – taxi-ing my children around (William is 8 and sport-mad and Emily is 5 and a horse-rider like her Mum) OR riding my horse ‘LJ ‘, who is an extremely handsome Cob.
So, is there anything else interesting about Caroline Timberlake that we really should know?
Just that I LOVE cheese and wine!
Business Development Director