Regulatory Affairs Professional
5 days ago
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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