Compliance and Licensing Expert
3 days ago
We are seeking a highly skilled Compliance and Licensing Expert to join our growing Regulatory Affairs Department at Cpl Life Sciences. This is a full-time, permanent position offering a salary of £35,000 to £40,000 + benefits. The role is based in the outskirts of Edinburgh, Scotland, UK and requires occasional travel to site.
The successful candidate will be responsible for managing product license registration with regulatory authorities worldwide. This includes preparing regulatory dossiers and supporting documentation, as well as maintaining registrations and licenses once granted. Key responsibilities include:
- Preparing and compiling regulatory documentation in compliance with ISO13485, IVD 2017/746 Regulation, FDA 21 Code of Federal Regulations (CFRs), Biologics License Applications (BLA), Medical Device Approvals (510(k)), Canadian Medical Device Regulations (CMDR) – Part 1, and other country requirements.
- Coordinating and executing regulatory submissions for countries including US, EU, Canada, and other territories in compliance with relevant regulations.
- Providing support to the Department Leader of Regulatory Affairs with regard to planning and coordination of activities, training, and supervision of junior staff.
What We Offer
Cpl Life Sciences offers a competitive salary, excellent benefits package, and opportunities for career growth and development.
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