Meet the Team - Dawn Vidgen
Role: QA/RA Associate
Started at Medovate: 25th Feb 2019
Dawn has worked in molecular research & development and related services for nearly 20 years. She joined Medovate as a Quality Assurance and Regulatory Affairs Associate at the beginning of 2019, working hands-on to support cutting-edge projects to expand our market reach, overseeing regulatory compliance, quality systems and quality assurance activities.
She talks us through the busy life of a QA/RA Associate at the company.
What does a 'typical' day involve for you?
As a QA/RA Associate, my role is to provide regulatory and quality expertise to Medovate, overseeing the daily maintenance of the quality management system and coordinating the documentation required for the devices that the company develops. A typical day involves project meetings, reviewing documentation and maintaining the QMS, with the objective to expand market access for our customers to various markets. Every device has its own regulatory strategy so proactive planning is a must.
What has given you greatest sense of achievement / pride while working at Medovate?
Obtaining CE mark approval for SAFIRA™ (SAFer Injection for Regional Anaesthesia this year has been a major stepping stone. With both CE Mark Approval and FDA Clearance, the device can now be readily integrated into markets across Europe and the US as well as other CE Mark territories, with potential to generate significant patient safety improvements across these regions. Bringing a device to market successfully is an incredibly arduous process involving a number of steps. Navigating the regulatory waters is the notoriously difficult part and includes obtaining FDA clearance for products in the US, and CE Mark approval for Europe. The aim is to ensure and validate the safety and effectiveness of the device.
What are the main challenges in your role (and how do you manage them?)
Documentation can be a pain point – especially chasing people to complete documentation correctly. But in terms of managing it, it’s just being proactive so putting in the effort to keep chasing, helping to understand the bottle necks and trying to reduce this. It takes a lot of communication and monitoring and taking a hands-on approach is key - the medical device industry is highly regulated, so no one can lax on quality.
What is the best thing about working at Medovate?
The team. There’s a lot of great things about working for the company and being part of a friendly and supportive team environment is definitely one of them. It means getting the best out of everyone has to offer and creating space for more reactive innovation.
Describe the Medovate culture in 3 words
Friendly, understanding and hardworking
And finally, a bit about yourself:
Favourite food: Mint chocolate
Favourite film: LOTR
What do you do to relax? Crafts – mainly cross stitching
Something your colleagues don't know about you? Once abseiled down a sub (in dry dock) for charity even though I’m petrified of heights.