Product Compliance Manager

3 weeks ago


Edinburgh, Edinburgh, United Kingdom Cpl Life Sciences Full time
Cpl Life Sciences Job Description

We are recruiting a Product Compliance Manager to join our team in Edinburgh, Scotland. This is a full-time, permanent position requiring 3x weekly on-site presence.

Estimated Salary: £45,000 per annum.

The successful candidate will be responsible for managing product license registration with global regulatory authorities. Key responsibilities include preparing and compiling regulatory documentation, coordinating submissions, and ensuring ongoing compliance with relevant regulations.

Main Responsibilities:

  • Prepare and submit regulatory dossiers and supporting documentation for ISO13485, IVD 2017/746 Regulation, FDA 21 Code of Federal Regulations (CFRs), and other country-specific requirements.
  • Coordinate with colleagues to gather data and information required for successful license applications.
  • Liaise with internal and external parties to support product labeling development and maintenance.
  • Stay up-to-date on new or updated regulations, guidance documents, and industry standards to ensure ongoing compliance.

Skills and Qualifications:

  • Bachelor's degree in a relevant field and/or equivalent work experience in regulatory affairs.
  • Prior experience in medical device / IVD / biotech industry preferred.

About Cpl Life Sciences:

  • We offer a competitive salary and benefits package.


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