Global Regulatory Lead

1 day ago


Edinburgh, Edinburgh, United Kingdom Cpl Life Sciences Full time

**About the Role:** We are seeking a highly skilled Medical Device Compliance Officer to join our Regulatory Affairs Department. In this role, you will be responsible for ensuring the compliance of our medical devices with global regulatory requirements.

**Key Responsibilities:

  • 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)), and Canadian Medical Device Regulations (CMDR).
  • Coordinating and executing regulatory submissions worldwide, ensuring timely and compliant registration of products.
  • Providing expert advice on data and information required for successful license applications and coordinating team efforts to ensure high-quality submissions.
  • Developing product labeling regulatory requirements for products, including package labels, product labels, and instructions for use.
  • Liaising with internal and external parties to support product labeling development.

**Requirements:** A relevant degree and/or experience in a regulatory affairs environment, along with specialist knowledge of vigilance processes for US, EU, and other jurisdictions. The ideal candidate will have previous experience preparing and submitting BLA, 510(k), PMA, CE mark, and technical files to worldwide regulatory authorities, as well as expertise in meeting with regulators and negotiating.



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