Senior QA/RA Specialist - Home Based

CK Group
18 Feb 2021
18 Mar 2021
Mary Bolt
Contract Type
Full Time
CK Science are recruiting for a Senior QA/RA Specialist for a rapidly growing research and development company in a home based position with occasional travel to Scotland.

The Company:

Our client is a medical technology company developing, manufacturing and marketing smart connected diagnostics and diagnostic-led care solutions.

Senior QA/RA Specialist Role:
You will be responsible for the quality and regulatory activities associated with IVD assays and Quality Controls through the design and development, verification and validation, transfer to manufacturing and release and post market phases.

Your main duties will be to:
  • Work with project teams to support in the design and development process and to ensure applicable standards and regulations for the products being brought to the market are incorporated throughout the development lifecycle.
  • Be responsible for supporting the Clinical and Medical Affairs teams both in pre and post market activities and ensuring that procedures followed are in compliance with ISO 13612 Performance evaluation of in vitro diagnostic medical devices.
  • Support the creation of the technical files for CE marking and ensure that clinical performance evaluations are conducted appropriately to fulfil the requirements of IVDR 2017/746 for Notified Body submission for CE marking and other global regulatory submissions.
  • Review and approve clinical protocols, clinical reports, clinical post market evaluations and clinical data and analysis

Your Background:
The ideal candidate for this role will have:
  • Education to degree level or above in life science or a related field with experience of working in an IVD or medical device environment in a similar QA/RA role.
  • Knowledge and experience of working to the appropriate quality and regulatory standards including ISO13485, FDA 21CFR Part 820.
  • Experience of working in an IVD or medical device environment with a strong quality and regulatory focus and experience through development and verification and validation activities.
  • Experience of pre and post launch IVD or medical device activities.

For more information or to apply for this Senior QA/RA Specialist position, please contact Mary Bolt on 01246 457729 or email, quoting job ref 49932.

It is essential that applicants hold entitlement to work in the UK.


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