Regulatory Affairs Specialist

4 weeks ago


Leeds, Leeds, United Kingdom Seven Life Sciences Full time

Job Title: Regulatory Affairs Specialist

Job Summary:

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Seven Life Sciences. As a Regulatory Affairs Specialist, you will be responsible for ensuring compliance with regulatory requirements for medical devices.

Key Responsibilities:

  • Review and update technical files for medical devices.
  • Conduct post-market surveillance activities.
  • Address internal and external regulatory inquiries.
  • Conduct internal audits.

Requirements:

  • 2-5 years of experience in Regulatory Affairs within the medical devices sector.
  • Strong knowledge of MDD and MDR.
  • Proficiency in ISO 13485.
  • Analytical and problem-solving abilities.
  • Excellent written and oral communication skills.

Desired Skills:

  • Writing post-market surveillance reports.
  • Reviewing technical files.
  • Clinical evaluations.


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