International Regulatory Manager

19 hours ago


Edinburgh, Edinburgh, United Kingdom Cpl Life Sciences Full time

About the Role:

We are seeking a highly skilled Regulatory Affairs Officer to join our team at Cpl Life Sciences.

Job Responsibilities:

The successful candidate will be responsible for:

  • Managing product license registration with regulatory authorities worldwide.
  • Preparing and compiling regulatory documentation, coordinating submissions, and advising staff on data requirements for license applications.
  • Liaising with internal and external parties to support the development of product labelling and ensure ongoing compliance with regulations.
  • Maintaining knowledge of new or updated regulatory requirements, guidance documents, and industry standards.

Requirements:

  • A relevant degree and/or work experience in a regulatory affairs environment.
  • Experience in a medical device / IVD / biotech industry, including specialist knowledge of 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.

Benefits:

The successful candidate will receive a competitive salary of £35,000-£40,000 per annum, plus benefits.

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