Regulatory Affairs Professional

5 days ago


Edinburgh, Edinburgh, United Kingdom Cpl Life Sciences Full time
Job Title: Regulatory Affairs Professional

At Cpl Life Sciences, we are seeking an experienced Regulatory Affairs Professional to join our team. This is a full-time position based on the outskirts of Edinburgh, Scotland, UK, requiring 3 days of site work per week.

The estimated salary for this role is £38,500 - £43,000. We offer relocation support for the right candidate and do not provide sponsorship but can consider international candidates who can relocate.

The successful candidate will be responsible for managing product license registrations with worldwide regulatory authorities, including preparation of regulatory dossiers and supporting documentation. They will also be responsible for maintaining registrations once granted.

Main Responsibilities:
  • Prepare and compile 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 as appropriate.
  • Prepare and compile regulatory documentation for countries including US, EU, Canada and any other territories as appropriate in compliance with ISO13485, IVD Directive 98/79/EC, IVD 2017/746 Regulation, FDA 21 Code of Federal Regulations (CFRs), Canadian Medical Device Regulations (CMDR) – Part 1 and other country requirements as appropriate.
  • Advise staff and project team members on data and information required for successful license applications and coordinate their efforts to ensure that their contributions to regulatory applications are produced to an appropriate standard for submission.
  • Develop product labelling regulatory requirements for products and for customer-contracted products including but not limited to package labels, product labels and instructions for use.
  • Liaise with internal and external parties as required to support the development of product labelling.
  • Contribute to the regulatory watch process by maintaining knowledge of new or updated regulatory requirements, guidance documents and industry standards.
  • Ensure maintenance of product regulatory documents and technical files (including US, EU, Japan, Brazil, Canada) to ensure ongoing compliance with ISO13485, IVD Directive 98/79/EC, 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).
  • Provide support to the Department Leader of Regulatory Affairs with regard to planning and co-ordination of activities and with regard to training and supervision of other members of the Regulatory Affairs team and to ensure continuous development of junior staff to develop their capabilities.


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