Coronavirus Test Device Approvals Scientific Advisor

Posted 05 January 2022
Salary£300 - £400 per day
Job type Temporary
DisciplineBiomedical Science JobsBiomedical scientist

Job description

Maxxima are currently recruiting for a a Coronavirus Test Device Approval Scientific Advisor to work with the DHSC.
The Team
Under regulation 39A of the Medical Devices Regulations 2002 the UK HSA has a duty to review and approve tests before they can enter the UK market. To deliver this regulatory function, every application needs to be assessed by a sufficiently skilled and trained Scientific Advisor (SA).
Following the implementation of this regulation we received approximately 170 applications to date of which only 10 have been processed to completion. The reason for the delay in processing is mostly due to the low quality of the applications, lacking information. To mitigate this, 53 applicants have been placed on the Secretary of State protocol, where there was a clear public health risk in those tests not being available. A new deadline was added, 31st December 2021, for all applicants to supply the remaining required information. 
We are therefore anticipating the need to review all of the applications to completion after that date. For those applications on the Protocol, this would need to be completed before the end of February 2022, when the protocol lapses. The current workforce of SAs will not be able to assess those protocol applications in time, plus any others that also return data. The limited scientific resources to assess the applications appropriately severely limits the ability of the team to deliver this project.
Delay in reviews poses a significant risk to the market’s ability to provide for testing demand as well as to the NHS to have access to sufficient testing to ensure ongoing health operations. It also means that the UK HAS is failing in its regulatory function to ensure that quality tests are on the UK market.
As Covid 19 will be an ongoing thread that will be managed rather than eradicated, UK HSA need to continue exploring new technology to quickly and adequately detect the virus (including variants such as Omicron), and to prevent spread. Therefore, new technology also requires resource to progress validation.
Job Description
The roles require scientists with current relevant laboratory experience, experience in validating and assessing the technical performance of assays, knowledge of quality assurance, regulatory requirements (UKAS ISO 15189/ 17205 standards, CE IVD, biosafety and MHRA regulations).  The below requirements are key:
  • Educated to master’s level or equivalent level of experience of working at a senior level in specialist area.
  • Knowledge and experience in researching, assessing technologies and writing scientific reports.
  • Extensive knowledge and experience of clinical diagnostic techniques relevant to SARS-CoV-2 including one or more molecular diagnostics, point of care testing, LAMP technologies, enzymology, mass spectrometry and antigen detection techniques including lateral flow.
  • Experience and knowledge of diagnostic testing environments including NHS, community, private and mobile testing environments.
  • A knowledge of emerging technologies, such as novel biosensors and breathomics would be advantageous along with experience of the challenges researchers and companies face in developing diagnostic tests. However, the above experience without this knowledge is still desirable.

 If you are interested in this vacancy, please apply by clicking the apply button. If you’d like more details about this role, contact the Biomedical team today – we always have time to take your call. If the role isn’t quite what you’re looking for, why not register with Maxxima today?

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