Regulatory Affairs Specialist

3 weeks ago


Edinburgh, Edinburgh, United Kingdom Cpl Life Sciences Full time

An exciting opportunity to work with Cpl Life Sciences as a Regulatory Affairs Specialist. This role is based in the outskirts of Edinburgh, Scotland, UK, with 3x a week on-site requirement. The estimated salary for this position is £35,000 to £40,000 + benefits.

The successful candidate will be responsible for managing product license registration with regulatory authorities worldwide, preparing and submitting documentation, and maintaining registrations/licences. 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 others, ensuring compliance with relevant regulations.
  • Advising staff and project team members on data and information required for successful license applications, coordinating their efforts to ensure high-quality submissions.
  • Developing product labelling regulatory requirements for products and customer-contracted products, including package labels, product labels, and instructions for use.
  • Liaising with internal and external parties to support product labelling development.
  • Maintaining knowledge of new or updated regulatory requirements, guidance documents, and industry standards through regular regulatory watch activities.
  • Ensuring maintenance of product regulatory documents and technical files for ongoing compliance with relevant regulations.
  • Providing support to the Department Leader of Regulatory Affairs regarding planning, coordination of activities, training, and supervision of junior staff.

Requirements for this role include a relevant degree and/or experience in a regulatory affairs environment, as well as expertise in vigilance processes for US, EU, and other jurisdictions. Previous experience preparing and submitting BLA, 510(k), PMA, CE mark, and technical files to worldwide regulatory authorities is also essential.



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