Job responsibilities
We are seeking a Regulatory Compliance Officer to support regulatory activities within RACU. The successful candidate will contribute to a wide range of regulatory and quality assurance functions, including but not limited to:
- Preparing documentation for regulatory submissions
- Assisting with technical file compilation and review
- Reviewing scientific validation and verification reports
- Supporting Post-Market Surveillance (PMS) processes
The role also involves developing a strong understanding of relevant Medical Device and IVD regulations, including ISO 15189, and engaging in regulatory intelligence to ensure ongoing compliance with evolving standards. Previous experience in regulatory affairs within a clinical or healthcare setting would be a distinct advantage.
The post holder must be highly organized, able to prioritise and manage multiple tasks simultaneously, and demonstrate strong attention to detail. Excellent interpersonal and communication skills are essential, as the role requires collaboration with colleagues across all levels and departments, both verbally and in writing.
Regulatory Compliance
- Ensure UKHSA products meet applicable regulatory requirements (e.g. UK MDR 2002, EU IVDR 2017/746, EU MDR 2017/745, ISO 13485, ISO 15189).
- Support continuous quality improvement across product development, manufacturing, and distribution activities
- Develop, implement, and maintain SOPs and ensure documentation practices are compliant with regulatory standards
- Conduct & support audits and inspections and assist with the closure of non-conformities and implementation of corrective actions
- Contribute to the investigation, documentation, and reporting of adverse incidents using relevant systems (e.g. TrackWise
- Support regulatory preparedness for inspections by UKAS, HSE, WHO, and MHRA
- Collaborate with internal teams to ensure being up to date on relevant regulations, regulatory compliance and provide guidance on regulatory matters
Quality Management & Administrative Support
- Support knowledge and information management, governance, risk management, planning, and reporting within the unit
- Organise and support meetings, including preparing agendas, reports, minutes, and tracking action items
- Maintain and develop databases and SharePoint sites to ensure effective documentation control and accessibility
- Contribute to the maintenance and improvement of the units Quality Management System (QMS), ensuring regulatory documentation and control processes are effectively implemented
- Provide administrative and coordination support, including handling internal and external enquiries, managing communications, and supporting cross-functional working groups or projects
- Deputise for team members as required and support the ongoing delivery of the units core functions
Professional & Technical Support
Provide regulatory and quality compliance support to UKHSA laboratories and projects.
Offer advice and guidance to internal stakeholders on regulatory obligations, best practices and compliance strategies.
Support technical and clinical networks on regulatory and quality related matters, contributing to collaborative initiatives across units.
Other
The duties listed above represent the key responsibilities of the role but are not exhaustive. You may be required to undertake additional reasonable tasks in line with organisational needs.
The job description and person specification will be reviewed periodically to reflect the evolving requirements of the organisation. Please not that this list is not exhaustive.Essential role criteria (including qualifications, licenses and registrations):
- Postgraduate Life Sciences qualification or demonstrable equivalent experience in Scientific/Regulatory roles
- Experience applying regulations and standards (e.g. ISO 13485, 15189, UK MDR, IVDR, CE marking) in a clinical or regulatory setting
- A commitment to learning about the regulation of medical devices in the UK
- Evidence of continuing professional development and willingness to continue the learning process through academic or practical experience
- Strong Microsoft Office and digital systems skills
- Excellent verbal and written communication, data analysis and statistical skills
- Experience of attending management meetings and presenting information to senior management
- Ability to work independently and as part of a team
- Excellent interpersonal, negotiating, and organisational skills, self-motivated, analytical and adaptable
- Follow relevant policies, procedures and legislation to complete your work.
- Able to make confident judgements, taking the initiative and seeking input from others were required to enable decision making by senior responsible owner
- Lead on multiple tasks with autonomy and minimal direction, often working under pressure
Desirable role criteria:
- Experience in regulatory compliance within the medical device or diagnostics sector
Selection Process DetailsStage 1: Application & Sift
This vacancy is using Success Profiles.
At sift stage you will be assessed against the 12 essential criteria listed in the job advert.
You will be required to complete an:
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.
Healthjobs UK has a word limit of 1500, but your supporting statement must be no more than 1000 words.
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 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.
Longlisting
In the event of a large number of applications, we may longlist into 3 piles of:
- Meets all essential criteria
- Meets some essential criteria
- Meets no essential criteria
We will take piles "Meets all essential criteria" and "Meets some essential criteria" through to shortlisting.
Shortlisting:
In the event of a large amount of applications, we will perform an initial sift, on the lead criteria of:
- Postgraduate Life Sciences qualification or demonstrable equivalent experience Scientific/Regulatory roles
- Experience applying regulations and standards (e.g. ISO 13485, 15189, UK MDR, IVDR, CE marking) in a clinical or regulatory setting
Desirable criteria may be used in the event of a large number of applications/large amount of successful candidates. Please note feedback will not be provided at this stage.
Stage 2: Interview (success profiles)
Behaviours, strengths and experience will be tested at interview.
You will be invited to a remote interview.
Interviews will be held in February 2026. Specific dates will be disclosed closer to the time.
This vacancy is being assessed using Success Profiles. During the interview we will assess you against the below:
Behaviours
We'll assess you against these behaviours during the interview process:
- Changing and Improving
- Making Effective Decisions (lead behaviour)
- Communicating and Influencing
- Managing a Quality Service
Once this job has closed, the job advert will no longer be available. You may want to save a copy for your records.
Additional Information
Eligibility Criteria
Open to all external applicants (anyone) from outside the Civil Service (including by definition internal applicants).
Security Clearance Level Requirement:
Successful candidates for this role must pass a standard disclosure and barring security check before they can be appointed.
Successful candidates must meet the security requirements before they can be appointed. The level of security needed is Basic Personnel Security Standard.
Location
This role is being offered as hybrid working based at any of our Core HQs. 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 HQs (Birmingham, Leeds, Liverpool, and London).
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).
Salary Information
Please note: 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.
Please be aware that the salary is based on the office location.
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