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Prif leoliad
Compliance
Gradd
Civil Service: Higher Executive Officer (HEO)
Contract
Parhaol
Oriau
  • Llawnamser
  • Rhan-amser
  • Rhannu swydd
  • Gweithio hyblyg
37.5 awr yr wythnos
Cyfeirnod y swydd
919-GB-301054-EXT
Cyflogwr
UK Health Security Agency
Math o gyflogwr
Public (Non NHS)
Gwefan
Bristol
Tref
Bristol
Cyflog
£33,422 - £46,580 AfC Band 6: £38,682 - £40,823 - £46,580 per annum, pro rata
Cyfnod cyflog
Yn flynyddol
Yn cau
16/10/2025 23:59

Teitl cyflogwr

UK Health Security Agency logo

Regulatory Compliance Officer

Civil Service: Higher Executive Officer (HEO)

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.

Trosolwg o'r swydd

We are seeking a Regulatory Compliance Officer (HEO or AfC Band 6)

Candidates holding HCPC registration will be appointed on NHS Terms & Conditions at NHS AfC Band 6. Candidates without HCPC registration will be appointed on Civil Service Terms and Conditions at HEO grade. 

The laboratory in Bristol is situated within the Severn Pathology suite of laboratories at North Bristol NHS Trust Southmead site. The laboratory receives in excess of 1 million specimens a year from a large number of clinical specialties across the Bristol and Bath hospital trusts which contribute to an interesting and varied workload.

The post-holder supports the Quality and IVD programme in Infection Sciences, Severn Pathology, working with the Quality Implementation and Compliance Manager, Operations Team and Technical Managers in complying with regulatory affairs, achieving, and maintaining high quality performance and supporting continual improvement in service delivery in all processes in accordance with UKHSA policies and procedures.

 

Prif ddyletswyddau'r swydd

The applicant must have a keen interest in quality management and be educated to degree level or equivalent in microbiology or a related pathology discipline.

The laboratory is accredited to ISO 15189:2022 and we actively encourage CPD activities.
In return we will provide a comprehensive induction programme and you will be appraised on a yearly basis with a view to developing knowledge and skills where appropriate.

In collaboration with the Infection Sciences Laboratories Bristol Quality Manager and team to become familiar with the area of work for which he/she is Regulatory Compliance Officer and be familiar with relevant statutory requirements, including awareness of regulatory acts, clinical governance, risk management, Caldicott and quality policies and procedure of UKHSA Bristol.

Gweithio i'n sefydliad

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

Swydd-ddisgrifiad a phrif gyfrifoldebau manwl

Main duties & responsibilities continued: 

Regulatory Compliance

  • To ensure that Infection Sciences Laboratories – Bristol comply with IVD regulations, relevant ISO and other accreditation standards in collaboration with the IVD Programme Core Team, Quality team, and other staff.
  • To take delegated regulatory and quality management tasks from the Quality Manager and deputy.
  • Work with others to fulfill the regulatory and quality related responsibilities and functions of the laboratories or units that the post holder is assigned to.
  • Provide practical support for preparation for and organization of inspections by third party assessors, such as UKAS, HSE and WHO assessors and to progress issues arising from these inspections.
  • Assist the laboratory Quality Team and Quality Manager to ensure compliance with IVDR Regulations.
  • Carry out regular internal audits and ensure that investigations and corrective actions are addressed in a timely manner.
  • To assist the notification of adverse incidents on the Governance Information System (Trackwise) and support the investigation and resolution of incidents.
  • To support the continuous improvement in service delivery and quality compliance within all areas of Infection Sciences Laboratories Bristol, using modern methods in ensuring the highest standards of quality, regulatory and process control.
  • To collaborate with the Quality Team and APCU Team within UKHSA, attending requirement meetings as required.
  • To implement the measuring and monitoring of key process indicators within the laboratory.
  • Assist laboratory staff to comply with applicable regulatory and quality standards.
  • To perform any other duties required by the line manager and deputise for the line manager.

Health & Safety

  • Collaborate with the Quality Manager to ensure that relevant UKHSA health and safety policies are implemented in collaboration with the safety team.
  • To ensure that incidents and accidents are reported on a timely basis and that the UKHSA’s statutory responsibilities for health, safety and welfare matters are fulfilled, e.g. Reporting of Injuries, Diseases and Dangerous Occurrences Regulations.
  • Liaise closely with Laboratory Safety Officers in collaboration with the Regulatory Compliance Manager to ensure that health, safety and welfare is afforded priority over other issues and to demonstrate a commitment to health, safety and welfare regarding self, staff and visitors.
  • Work in a safe manner, report all accidents and incidents, comply with safety policies and procedures and participate in the internal and external safety audits, as required.
  • Co-operate on mattes of health and safety to enable the UKHSA to comply with its health and safety responsibilities.
  • Liaise with the Laboratory Safety Officer and Quality Manager to help resolve safety and quality issues highlighted through quality related activities.
  • To attend mandatory fire, manual handling training, etc.

Your attention is drawn to the Health and Safety at Work, etc. Act 1974 which requires you to take reasonable care of the health and safety of yourself and others which may be affected by your acts and omissions at work; and co-operate with the UKHSA on matters of health and safety.

Communication

  • To communicate effectively and accurately by oral and written means, and to ensure full and effective communication throughout the laboratory, making certain that all staff are included where appropriate
  • To attend training meetings, tutorials, lectures and conferences, etc.
  • To take responsibility for internal communications.

Information Technology

  •  Apply computer databases, word processing and other specialized software packages to all aspects of maintaining and developing quality systems, in particular Q-Pulse quality management software to support the quality systems in UKHSA Bristol.
  •  Use databases and software packages.

Other

  • The above is only an outline of tasks, responsibilities and outcomes required of the role.  You will carry out any other duties as may reasonably be required by the Quality Manager, Head of Technical Services, or Head of Business Operations.
  • The job description and person specification may be reviewed on an ongoing basis in accordance with the changing needs of the organization

Essential role criteria:

  • Science degree (biological science, environmental science, biomedical science, statistics) or equivalent in microbiology or a related pathology discipline OR Health and Care Professions Council – State Registration Biomedical Scientist/Clinical Scientist 
  • Evidence of continuing professional development and willingness to continue the learning process through academic or practical experience
  • Sound knowledge of common IT programmes, including Q-Pulse and excellent keyboard and IT skills
  • Substantial laboratory experience working in an accredited medical laboratory
  • Experience in applying a range of standards, regulations and guidelines applicable to clinical laboratories
  • Understanding of IVD governance principles and procedures
  • Understanding and experience of change management
  • Experience of implementing projects
  • Excellent verbal and written communication, data analysis and statistical skill
  • Ability to work on own initiative and as part of the team
  • Excellent interpersonal, negotiating, and organisational skills, self-motivated, analytical and adaptable
  • An understanding of and commitment to equality of opportunity and good working relationships

Desirable role criteria:

  • Quality management qualification and knowledge of Regulatory compliance
  • An understanding of microbiology and its application in clinical practice and public health

Selection Process Details:

This vacancy will be assessed using a competency-based framework which will assess your qualifications, knowledge and experience and / or skills and abilities outlined in the essential criteria.  

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)
  • 1000 word supporting statement 

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

The Application form and supporting statement will be marked together. 

Longlisting:

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

  • Meets all essential criteria 
  • Meets some essential criteria 
  • Meets no essential criteria  

The following will be taken through to the next stage:

  • Meets all essential criteria 

Shortlisting:

In the event of a large number of applications we will shortlist on the following: 

  • Substantial laboratory experience working in an accredited medical laboratory

Desirable criteria may be used in the event of a large number of applications / large amount of successful candidates.

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

Please do not exceed 1000 wordsWe will not consider any words over and above this number. 

Feedback will not be provided at this stage. 

Please note you will not be able to upload your CV. You must complete the application form in as much detail as possible. Please do not email us your CV.

Stage 2: Interview (competency based) 

You will be invited to a (single) face to face interview at the Bristol site. If face to face interviews are planned, in exceptional circumstances, we may be able to offer a remote interview. 

Knowledge, experience, skills & abilities will be tested at interview.    

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

Eligibility Criteria - External  

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

Location 

This role is being offered as office/lab based at our site in Bristol.

If based at one of our labs, you will be required to have 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 disclosure and barring security check.   

Successful candidates must meet the security requirements before they can be appointed. The level of security needed is Counter-terrorist Check.

 

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). 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.  

Manyleb y person

application form and supporting statement

Meini prawf hanfodol
  • application form and supporting statement

Essential Criteria

Meini prawf hanfodol
  • Questions on experience, knowledge and skills

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