Senior Regulatory Compliance Specialist

5 days ago


Leeds, Leeds, United Kingdom CV-Library Full time

A prestigious Medical Device company in West Yorkshire is seeking a skilled Senior Regulatory Compliance Specialist to oversee Regulatory Compliance efforts across the organization.

This critical role involves collaborating closely with the Regulatory Affairs Manager to ensure the creation, review and updating of Technical Files, as well as leading Post Market Surveillance initiatives and conducting Internal Audits. The ideal candidate will possess extensive experience in the Medical Device sector, with a deep understanding of Technical File management, PMS activities and MDD/MDR compliance.

Responsibilities:
  • Ensure adherence to MDD & MDR regulations
  • Develop and maintain Technical Files
  • Coordinate Post Market Surveillance
  • Foster a culture of Regulatory Compliance
  • Plan and execute Internal Audits

We anticipate a salary range of £50,000 - £65,000 per annum for this Senior Regulatory Compliance Specialist position, reflecting the significant responsibility and required expertise.



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