Regulatory Affairs Professional

5 days ago


Bracknell, Bracknell Forest, United Kingdom HealthHero Group Full time
Job Title: Regulatory Affairs Professional

Estimated Salary: £70,000 - £90,000 per annum

About the Role:

We are seeking a highly skilled Regulatory Affairs Professional to join our Clinical Product Team at HealthHero Group. As a key member of the team, you will be responsible for ensuring the quality and compliance of our medical devices throughout their entire lifecycle.

Key Responsibilities:

  • Provide support and guidance to the organisation on all aspects of product quality, compliance, and governance.
  • Manage the creation and maintenance of Clinical Product Safety Documentation and Technical Files.
  • Ensure compliance with clinical risk management standards through manufacturing, implementation, and documentation.

Requirements:

  • Knowledge and experience of quality management and the governance of medical devices within an ISO 13485 accredited healthcare organisation.
  • Desirable – have experience of software as a medical device including MDR submissions.

Benefits:

  • Company Pension scheme.
  • Access to HealthHero healthcare services, including Private 24/7 GP service and Employee Assistance Programme.
  • 25 days holiday + 8 days bank holiday and an extra day off for your birthday.


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