Global Regulatory Coordinator

1 week ago


London, Greater London, United Kingdom Cpl Life Sciences Full time

Cpl Life Sciences is a leading provider of IVD solutions. We are currently seeking a highly skilled Global Regulatory Coordinator to join our team.

Main responsibilities:

  • Preparing and compiling regulatory documentation, coordinating and executing regulatory submissions 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, coordinate and execute regulatory submission 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.
  • 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).

The ideal candidate will have a relevant degree and/or relevant work experience in a regulatory affairs environment. Experience in a medical device / IVD / biotech industry is also essential.

We offer a competitive salary range of £35,000 to £40,000 + benefits, making this an attractive opportunity for those looking to develop their career in regulatory affairs.



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