Regulatory Affairs Team Lead
IVD
Edinburgh
I am very pleased to be able to offer this role with one of our established clients. With a global presence and several large sites, this is a great opportunity to take your regulatory experience global and work within the UK, EU, APAC and US markets! They recently received impressive funding for a new product and are taking over the cutting edge diagnostics space.
This role will be leading a small team across new products and continuing surveillance for one of their most successful product portfolios.
Key Requirements:
* UK, EU and US regulatory submission experience is ideal but we can consider individual merit
* Experience leading 510(k) submissions would be ideal
* Experience in CE marking, PMS activities for global diagnostics
* A people orientated personality / previous team lead experience
Why Apply?
* No doubt the diagnostics world has been shaken after the COVID-19 situation, but on offer is a stable position, with a business who have been operating for 17 years. They now have over 300 employees across multiple sites and a successful product portfolio.
* A flexible working model, hybrid in one of the UK's best cities!
* What the team describe as a positive, supportive culture with on-site facilities, regular social incentives if you want to partake, and health and wellbeing initiatives.
Apply now by hitting 'easy apply' or emailing dion@entrustrs.com