Senior Regulatory Affairs Associate, Broughton
Client:
Entrust Resource Solutions
Location:
Broughton, United Kingdom
Job Category:
Other
EU work permit required:
Yes
Job Views:
5
Posted:
31.05.2025
Expiry Date:
15.07.2025
Job Description:
Regulatory Affairs Team Lead
IVD
Location: Edinburgh
I am pleased to offer this role with an established client that has a global presence and several large sites. This is a great opportunity to expand your regulatory experience across the UK, EU, APAC, and US markets, especially as they are advancing in the diagnostics space with new funding for innovative products.
This role involves leading a small team managing new products and ongoing surveillance for a successful product portfolio.
Key Requirements:
* Experience with UK, EU, and US regulatory submissions is preferred, but individual merit is considered
* Experience leading 510(k) submissions is advantageous
* Experience with CE marking and PMS activities for global diagnostics
* Leadership qualities and previous team lead experience
Why Apply?
* Stable position in the diagnostics industry, operating for over 17 years with 300+ employees
* Flexible hybrid working in Broughton, UK
* Supportive team culture, on-site facilities, social events, and health initiatives
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