Regulatory Affairs Specialist

3 days ago


Edinburgh, Edinburgh, United Kingdom Hobson Prior Full time

Hobson Prior is a leading recruitment agency in Edinburgh, and we are currently seeking a Regulatory Affairs Specialist to join our client's team. The estimated salary for this position is £45,000 - £55,000 per annum.

Job Description

This role involves preparing and compiling regulatory documents, coordinating and executing regulatory submissions for various countries, and ensuring compliance with relevant regulations and standards.

  • Main Responsibilities:
  • Prepare and compile regulatory documents for submission in various countries.
  • Advise team members on data and information needed for successful license applications.
  • Maintain product regulatory documents and technical files to ensure ongoing compliance.
  • Communicate changes to regulatory authorities as needed.
  • Assist with implementing the company's quality policy to ensure compliance with relevant standards and regulations.
  • Contribute to the design and improvement of regulatory processes.
  • Provide support, guidance, and training to team members.
Key Skills and Requirements
  • Experience in regulatory affairs, particularly with in vitro diagnostics (IVD).
  • Strong understanding of regulatory requirements and standards.


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