The announcement comes shortly after Europlaz's completion of a £3.5m investment drive in new machinery and technology.
The business also believes there is a £1m opportunity for Europlaz to help new UK innovators to navigate the costly and time expensive process of medical device compliance.
The former design engineer, who has more than twenty-four years’ experience in medical devices, has spent the last decade in regulatory affairs with a strong focus on both the EU MDR (2017/745) and the UK MDR 2002 regulations.
His initial remit as Europlaz’s Person Responsible for Regulatory Compliance (PRRC) will be to look after devices where the company is classified as the legal manufacturer on behalf of clients, as well as ensuring conformity of its own product range, including neonatal flow sensors.
“I’ve had a lot of experience in the corporate sector, so when the opportunity came up to join a family-led business with a passion to make a difference, it was too good to turn down,” explained Alastair.
“My background is slightly different to most people in my position. I trained as a design engineer and have also worked in product engineering prior to my transition to regulatory affairs - so I can understand both sides of the product journey.”
He continued: “This really helps me build trust with the production teams and we can tailor design/manufacturing to ensure the required outcome for the client, but importantly that it conforms with all the technical, safety and regulatory requirements expected by the UK, the EU and internationally.
“Regulatory Affairs can be a very complex landscape, a landscape that can deter some innovators from moving into this space. I believe we can remove those barriers for them and deliver a one-stop solution to get their product to market. This could be a major growth area for us.”
Alastair replaces David Bacon, who spent more than 17 years at Europlaz, firstly in the Quality department and then, in more recent years, as head of Regulatory Affairs. He will continue to use his extensive knowledge in a consultancy role for the business.
Since the 19060's, Europlaz has been developing and providing knowledge on tooling, technical injection moulding, assembly, packaging and product management. It also develops prototyping, tool modification, sterilisation and distribution services
