Global Regulatory Manager
13 hours ago
We are seeking a Global Regulatory Manager to join our team 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:
- Developing and implementing global regulatory strategies 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.
- Liaising with internal and external parties to support the development of product labelling, including package labels, product labels, and instructions for use.
- Maintaining knowledge of new or updated regulatory requirements, guidance documents, and industry standards.
Requirements
The ideal candidate will have a relevant degree and/or relevant work experience in a regulatory affairs environment. They should also have specialist knowledge of vigilance processes for US, EU, and other jurisdictions, as well as previous experience preparing and submitting BLA, 510(k), PMA, CE mark, and technical files to worldwide regulatory authorities.
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