QARA Specialist


QARA Specialist

1 week ago

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My client, a growing medical devices company is looking for an experienced QA/RA specialist to join them on a remote basis. You’ll be part of an intimate team, responsible for the management of QMS whilst being the main person in charge of all regulatory affair activities.

Responsibilities will include:

  • Management of QMS (such as ISO 9001).
  • Negotiating and liaising with global suppliers, making sure everything is compliant to UK regulations.
  • Communicating and negotiating with notified bodies such as the MHRA.
  • Ensuring all work is compliant with IVDR and UKCA

Ideal candidate:

  • 2+ years’ experience within Regulatory and Quality.
  • Experience with CE / UKCA marking or certification.
  • Experience working and communicating with manufactures.
  • Experience working with UK regulatory bodies such as the MHRA.
  • Understanding of CE / UKCA and IVDR.

We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.


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Hannah Hughes

Email Hannah
41 4455 14610

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