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Quality and Regulatory Affairs Officer

This is an exciting opportunity for a talented individual with background in Quality Management System and Regulatory Affairs. Reporting to our QA/RA head, you will play a pivotal role within the organisation helping in the development and maintenance of Mint Diagnostics’ Quality Management System.

We are looking for an enthusiastic, pragmatic, self-motivated, organised individual with a keen eye for detail and some previous experience of working in a regulated environment (ISO 13485:2016).

Location: Kent

Position: Full time

Key responsibilities:

  • Maintenance of compliance to ISO13485
  • Create analytical reports
  • Support the Quality/ Regulatory head to:
    • ensure strategic and operational QA/RA management
    • build and extend internal IVDR & MDR capabilities
    • advise project development team on potential Regulatory and Quality trajectories
    • implement and follow up of QA/RA document requirements
    • apply for regulatory submissions including liaison with notified bodies
    • ensure compliance of the lab service team activities to medical/testing laboratory regulations

Required:

  • Bachelor’s degree in relevant discipline
  • 2 years’ experience of working with QMS/ISO certificate maintenance for medical devices
  • Attention to detail
  • Strong grasp of formal English and excellent writing and editing skills
  • Ability to work well and collaborate within a team environment
  • Ability to work with minimal supervision
  • Flexible and proactive
  • Strong organisational skills

Desired:

  • Have a strong knowledge of ISO13485 and knowledge of other relevant standards
  • Experience with IVD development, including knowledge of the regulatory context (IVDR/MDR/FDA)
  • An understanding of COSHH and Health and Safety regulations
  • Familiarity with medical diagnostics/testing laboratories regulations

To apply, please submit your CV and cover letter by email to: careers@mintdiagnostics.com

About Mint Diagnostics:

Mint Diagnostics is a start-up re-defining how hormone data can be collected and used for human performance optimisation and personalised healthcare in fields such as IVF and oncology.

Want to unlock the power of hormone monitoring?

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