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Job summary

Main area
Healthcare Scientist
Grade
Civil Service: Senior Executive Officer (SEO)
Contract
Permanent
Hours
  • Full time
  • Part time
  • Job share
  • Flexible working
37.5 hours per week
Job ref
919-CG-300319-EXT
Employer
UK Health Security Agency
Employer type
Public (Non NHS)
Site
Core HQ or Scientific Campus
Town
Birmingham, Leeds, Liverpool, London, Porton
Salary
£41,983 - £52,113 per annum, pro rata
Salary period
Yearly
Closing
27/04/2026 23:59

Employer heading

UK Health Security Agency logo

Healthcare Scientist

Civil Service: Senior Executive Officer (SEO)

The United Kingdom Health Security Agency (UKHSA) is a system leader for health security; taking action internationally to strengthen global health security, providing trusted advice to government and the public and reducing inequalities in the way different communities experience and are impacted by infectious disease, environmental hazards, and other threats to health.

UKHSA’s remit, as an agency with a global-to-local reach, is to protect the health of the nation from infectious diseases and other external threats to health. As the nation’s expert national health security agency UKHSA will:

  • Prevent: anticipate threats to health and help build the nation’s readiness, defences and health security
  • Detect: use cutting edge environmental and biological surveillance to proactively detect and monitor infectious diseases and threats to health
  • Analyse: use world-class science and data analytics to assess and continually monitor threats to health, identifying how best to control and mitigate the risks
  • Respond: take rapid, collaborative and effective actions nationally and locally to mitigate threats to health when they materialise
  • Lead: lead strong and sustainable global, national, regional and local partnerships designed to save lives, protect the nation from public health threats and reduce inequalities.

Job overview

The IVD Programme covers the regulation, management and governance of in-vitro diagnostic medical devices (IVDs) used for patient management within Public Health Microbiology (PHM) Directorate. Both in-house and commercial IVDs are included in its remit. The aim of the programme is to migrate all IVDs into regulatory compliance.   

The Regulatory Assurance and Compliance Unit (RACU) has responsibility for review and update of standards, guidelines, and templates; manages the device proposal and authorisation system; reviews IVD validation documents; has oversight of surveillance systems; and maintains a register of IVDs used. The RACU acts as a focal point for communications with the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA).  

The regulations are currently in transition from The Medical Devices Regulations 2002 to GB specific regulations informed by the Medicines and Medical Devices Act 2021.  MHRA have advised to continue to use the EU IVDR as a guide while awaiting final confirmation of the GB regulations.  Best practice oversight is also within the RACU remit, covering non-IVD assays such as UKHSA R&D and surveillance assays, so as to meet comparable standards to those for IVDs.

Main duties of the job

  • Lead on the scientific support for IVD governance
  • Provide technical expertise to RACU
  • Provide scientific advice and guidance and make recommendations to laboratory directors and departmental managers in achieving and maintaining IVD governance, working specifically as part of the IVD Compliance Project to ensure compliance with regulatory standards & in accordance with UKHSA policies and procedures.  

Please note, this list is not exhaustive.

Working for our organisation

We pride ourselves as being an employer of choice, where Everyone Matters promoting equality of opportunity to actively encourage applications from everyone, including groups currently underrepresented in our workforce.   

UKHSA ethos is to be an inclusive organisation for all our staff and stakeholders. To create, nurture and sustain an inclusive culture, where differences drive innovative solutions to meet the needs of our workforce and wider communities. We do this through celebrating and protecting differences by removing barriers and promoting equity and equality of opportunity for all.  

Please visit our careers site for more information https://gov.uk/ukhsa/careers

Detailed job description and main responsibilities

The above and below lists are only an outline of the tasks, responsibilities and outcomes required of the role. The post holder may carry out any other duties as may reasonably be required. The job description and person specification may be reviewed on an ongoing basis in accordance with the changing needs of the organisation.  

  • Support RACU in migrating PHM to compliance for in-house and commercial IVDs  
  • Project manage validation and verification assessments, in collaboration with RACU and PHM Lab departments.  
  • Play a leading role in the assessment of new technologies and diagnostic tests to enhance the laboratories capabilities and ensure that the high scientific standards are followed. 
  • Work independently and with the RACU Operations team to generate outputs to agreed timescales  
  • Familiarisation with IVD Regulations, maintaining awareness of updates where applicable. 
  • Work with RACU to streamline and deploy existing cross laboratory validation documents as a manageable number of clear templates to comply with regulatory and MHRA guidelines, and existing or new guidelines from UKAS. Maintain awareness of relevant IVD standards (e.g. standard operating procedures, UK Standards for Microbiology Investigations) and perform gap analyses
  • Inform the MHRA, where device performance or safety matters are considered to conflict with the manufacturer’s claims for intended use and/or CE or UKCA Marking status 
  • Advise and direct laboratory staff to comply with all relevant standards 
  • Suggest improvements and act on team improvement suggestions where necessary
  • Liaise closely with laboratory and quality managers to ensure they are aware of IVD-related activities and issues in their departments 
  • Represent the RACU Operations Team at relevant meetings and seminars as necessary, undergo any training requirements as required for the post
  • Maintain high professional standards by continual professional development keeping up to date with advances in medical microbiology 
  • Maintain a positive attitude to the work of the RACU Operations Team and related personnel   
  • Identify to management any potential conflicts of interest which may impinge on their ability to perform their duties effectively as defined by UKHSA Conflict of Interest Policy. 
  • Ensure health, safety and welfare are afforded priority and demonstrate commitment to health, safety and welfare of self, staff and visitors and comply with relevant UKHSA health and safety policies at all times  

Essential Criteria: 

  • Science degree or equivalent in microbiology or a related pathology discipline
  • Postgraduate scientific qualification or demonstrable equivalent experiential learning gained in a medical laboratory environment, alongside evidence of continuing professional development
  • Knowledge and experience of IVD validations/verifications
  • Substantial recent experience working in an accredited clinical diagnostic or reference virology or bacteriology and; 
  • Knowledge of IVD regulations (e.g. IVDR) and experience in applying a range of standards, regulations and guidelines applicable to clinical laboratories
  • Understanding and experience of change management
  • Good knowledge and experience of serological methods including ELISA and IFA; and of molecular diagnostics methods including but not limited to NAATs, PCR, sequence analysis, whole genome – and/or next generation genome – sequencing
  • Experience of leading and managing projects
  • Excellent verbal and written communication, including experience of writing and preparing reports for senior management, data analysis and statistical skills
  • Experience of attending management meetings and presenting information to management.
  • Ability to work on own initiative and as part of a team
  • Excellent interpersonal, negotiating and organisational skills, self-motivated, analytical and adaptable 

Desirable Criteria

  • Wide experience of common office software applications, using and setting up databases, e.g. Jira
  • Knowledge of GxP & safety requirements 

Selection Process Details

This vacancy is using Success Profiles and will assess your Behaviours,  Experience and Technical skills.   

Stage 1: Application & Sift  

You will be required to complete an application form. You will be assessed on the listed 12 essential criteria, and this will be in the form of a:  

  • Application form (‘Employer/ Activity history’ section on the application) 
  • 1500 word supporting statement. 

This should outline how you consider your skills, experience and knowledge provide evidence of your suitability for the role, with reference to the essential criteria. 

You will receive a joint score for your application form and statement. (The application form is the kind of information you would put into your C.V –please be advised you will not be able to upload your CV. Please complete the application form in as much detail as possible). Please do not email us your CV. 

Longlisting:

In the event of a large number of applications we will longlist into 3 piles of: 

  1. Meets all essential criteria  
  2. Meets some essential criteria  
  3. Meets no essential criteria  

If used, the piles ‘Meets all essential criteria’ and ‘Meets some essential criteria’ will proceed to shortlisting.

Shortlisting:

In the event of a large number of applications we may conduct an initial sift, on the lead criteria of:

  • Postgraduate scientific qualification or demonstrable equivalent experiential learning gained in a medical laboratory environment, alongside evidence of continuing professional development
  • Substantial recent experience working in an accredited clinical diagnostic or reference virology or bacteriology
  • Knowledge of IVD regulations (e.g. IVDR) and experience in applying a range of standards, regulations and guidelines applicable to clinical laboratories

If you are successful at this stage, you will progress to interview.

Feedback will not be provided at this stage. 

Stage 2: Interview

You will be invited to a single remote  interview.  

Behaviours and Technical skills will be tested at interview.

The Behaviours tested during the interview stage will be:

  • Making Effective Decisions (Lead behaviour)
  • Communication and Influencing
  • Managing a Quality Service

Technical Skills will be assessed via technical based questions.

Interviews dates to be confirmed. 

Once this job has closed, the job advert will no longer be available. You may want to save a copy for your records. 

Location

This role is being offered as hybrid working based at any of our Core HQ’s or at our Scientific Campus in either London (Colindale) or Porton.

We offer great flexible working opportunities at UKHSA and operate using a hybrid working model where business needs allow. This provides us with greater flexibility about how and where we work, to get the best from our workforce. As a hybrid worker, you will be expected to spend a minimum of 60% of your contractual working hours (approximately 3 days a week pro rata, (averaged over a month) working at one of UKHSA's core HQ’s (Birmingham, Leeds, Liverpool, and London) or at one of our scientific campus sites (Colindale, Porton). Our core HQ offices are modern and newly refurbished with excellent city centre transport link and benefit from benefit from co-location with other government departments such as the Department for Health and Social Care (DHSC).

If based at one of our scientific campuses, you will be required to have a minimum of a Counter Terrorism Check security vetting check as a minimum. For meaningful National Security Vetting checks to be carried out individuals need to have lived in the UK for a sufficient period of time. You should normally have been resident in the United Kingdom for the last 3 years as the role requires Counter Terrorism Check (CTC) clearance. In exceptional circumstances UK residency less than the outlined periods may not necessarily bar you from gaining national security vetting and applicants should contact the Vacancy Holder/Recruiting Manager listed in the advert for further advice.

Security Clearance Level Requirement  

Successful candidates must pass a standard disclosure and barring security check.   

Successful candidates must meet the security requirements before they can be appointed. The level of security needed is Baseline Personnel Security Standard or Counter Terrorism Check. This will be dependant on your chosen office location.

Eligibility Criteria

Open to all external applicants (anyone) from outside the Civil Service (including internal applicants).   

Salary Information 

If you are successful at interview, and are moving from another government department, NHS, or Local Authority, the relevant starting salary principles for level transfers or promotions will apply. Otherwise, roles are offered at the pay scale minimum for the grade, but in exceptional circumstances there may be flexibility if you are able to demonstrate you are already in receipt of an existing, higher salary. Pay increases are through the relevant annual pay award for the role and terms. 

Senior Executive Officer (SEO)  

  • £41,983- £48,128 (National)
  • £44,148£50,121 (Outer London)
  • £46,310£52,113 (Inner London) 

Person specification

Application form and supporting statement

Essential criteria
  • Application form and supporting statement

Behaviours

Essential criteria
  • Making Effective Decisions (Lead)
  • Communication and Influencing
  • Managing a Quality Service

Technical Skills

Essential criteria
  • Technical based questions

Employer certification / accreditation badges

Purple SpaceApprenticeships logoNo smoking policyAge positiveImproving working livesMindful employer.  Being positive about mental health.Disability confident employerThe Employers Network for Equality & Inclusion (enei) is the UK's leading employer network covering all aspects of equality and inclusion issues in the workplace.Carer Confident -AccomplishedHappy to Talk Flexible Working

Applicant requirements

The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.

Documents to download

Apply online now

Further details / informal visits contact

Name
Charlene Gwekwerere
Job title
Resourcing Support Officer
Email address
[email protected]
Additional information

For further information relating to the role please contact Peter Marsh - [email protected]

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