Regulatory Compliance Officer

UK Health Security Agency; Greater London; Hybrid; GBP 30,000 - 50,000; Full time

Job summary

A government health organization is seeking a Regulatory Affairs professional in London to ensure compliance with medical device regulations. The candidate will work within a dynamic team focusing on regulatory compliance and oversight of medical devices. Ideal backgrounds include a postgraduate qualification in Life Sciences and experience in regulatory affairs. This role offers ample opportunity for professional development within a forward-thinking organization committed to health security.

Benefits

Flexible working patterns

Professional growth opportunities

Qualifications

• Experience applying regulations and standards in a clinical or regulatory setting is preferred.
• Strong attention to detail and excellent organizational skills are required.
• Ability to manage multiple tasks simultaneously in a proactive manner.

Responsibilities

• Ensure compliance with medical device and quality regulations.
• Assist with audits, inspections, and documentation management.
• Support training and best practice initiatives across the organization.

Skills

Regulatory compliance

Quality management

Interpersonal communication

Data analysis

Microsoft Office proficiency

Education

Postgraduate Life Sciences qualification

Tools

TrackWise

Job description

Job Overview

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.

• 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 Are you looking to begin your career in regulatory affairs within the medical devices sector? Do you want to play a key role in ensuring patient safety and maintaining compliance with evolving regulatory standards?? Have you considered joining a dynamic team that offers excellent opportunities for professional growth and development? If so, this could be the opportunity you've been seeking. We have an exciting opening to join Regulatory Assurance Compliance Unit (RACU) team, contributing to regulatory compliance and product oversight. This is a unique chance to be part of a forward‑thinking organization advancing its regulatory capabilities to support the procurement and/or manufacture of safe, effective medical devices—including in vitro diagnostics (IVDs) and software as medical devices (SaMD)).

UKHSA is a legal manufacturer and a distributor of medical devices (MDs), including in vitro diagnostics (IVDs), Software as medical device (SaMD) and related accessories. These devices fall under two main categories: 1) Commercial MDs/IVDs: Intended for market distribution and requiring full regulatory compliance. 2) In‑house IVDs: Used exclusively on UKHSA premises under the Health Institution Exemption (MHRA guidance). UKHSA maintains a robust and compliant Quality Management System (QMS) to support these functions.

Regulatory Compliance Tasks

• Ensure UKHSA products meet all relevant medical device and quality regulations (UK MDR, EU IVDR/MDR, ISO 13485, ISO 15189)
• Support audits, inspections, and post‑market activities, ensuring continuous quality improvement and regulatory readiness
• Maintain and enhance SOPs, QMS documentation, and compliance systems across development, manufacturing, and distribution
• Provide regulatory and quality guidance to internal teams and projects, promoting best practice and compliance awareness
• Manage documentation, reporting, and coordination activities to support effective governance and operational delivery

This role is based within the RACU team and offers the opportunity to collaborate with colleagues across the wider organisation. Working alongside a highly motivated and dedicated team, you will be responsible for managing compliance activities and contributing to regulatory intelligence and strategy. Reporting to the team's Scientific/Regulatory advisor, you will build and maintain strong relationships with stakeholders to ensure all regulatory requirements are met efficiently and effectively. Please note this list is not exhaustive.

Regulatory and Quality Assurance Functions

• 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 unit's 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 unit's 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.

Application Process

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) and a 1000 word supporting 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

Shortlisting: In the event of a large number of applications, we will perform an initial sift, on the lead criteria of:

• 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 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, Artificial Intelligence can be a useful tool to support your application, however, all examples and statements provided must be truthful, factually accurate and taken directly from your own experience. Where plagiarism has been identified (presenting the ideas of others, or generated by artificial intelligence, as your own) applications may be withdrawn and internal candidates may be subject to disciplinary action. Please see our candidate guidance for more information on appropriate and inappropriate use.

Link below: Artificial intelligence and recruitment | Civil Service Careers This is a Non‑Reserved post under the Civil Service Nationality Rules. To be eligible for employment in the UK Civil Service applicants must meet the Civil Service Nationality Rules (CSNRs) which operate independently of and additionally to the Immigration Rules. Applicants must also meet necessary security and vetting requirements, along with any other relevant pre‑employment checks.

This job is broadly open to the following groups:

• UK nationals
• nationals of the Republic of Ireland
• nationals of Commonwealth countries who have the right to work in the UK
• nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities with settled or pre‑settled status under the European Union Settlement Scheme (EUSS) (opens in a new window)
• nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities who have made a valid application for settled or pre‑settled status under the European Union Settlement Scheme (EUSS)
• individuals with limited leave to remain or indefinite leave to remain who were eligible to apply for EUSS on or before 31 December 2020
• Turkish nationals, and certain family members of Turkish nationals, who have accrued the right to work in the Civil Service

For more information on job nationality requirements and the right to work in the UK, see the Civil Service Nationality rules. For further details, please refer to the information sheet.

We also promote flexible working patterns (part‑time, job‑share, condensed hours). UKHSA operates a hybrid working model where business needs allow, providing flexibility about where you work.