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About the Role

The Medicines and Healthcare products Regulatory Agency (MHRA) is seeking a Diagnostic Regulatory Specialist to join the Innovative Devices Function within the Health Quality and Access group. This role focuses on diagnostics and supports the development and implementation of the future regulatory framework for medical devices, involving leadership on specific areas, collaboration with internal teams and external stakeholders, and providing expert regulatory advice to manufacturers.

Responsibilities

Take ownership of delivering key elements of the new medical devices regulatory regime, including contributing scientific, technical and policy input to future legislation and implementation.
Work with DHSC, Government Legal Department and partners to develop secondary legislation, and support Parliamentary briefings and debates to ensure delivery against key milestones.
Provide scientific, technical and policy input to support implementation of the regulatory framework through clear guidance and regulatory advice, ensuring outputs meet stakeholder needs and align with legislative requirements.
Oversee delivery of the in vitro Diagnostics (IVD) roadmap, tracking progress against milestones, coordinating input across teams, and ensuring alignment with wider regulatory plans.
Support international engagement with other regulators, including at the International Medical Devices Regulators Forum (IMDRF).
Lead a small team.
Contribute to the provision of expert regulatory advice to medical device and IVD device manufacturers.

Requirements

Minimum of a Bachelors degree or equivalent experience.
Working knowledge of the UK and/or EU Medical Devices legislation.
Experience of communicating with a range of stakeholders in the development and / or delivery of policy objectives.
Experience of policy development in a regulatory environment with ability to draft a range of policy and guidance documents for different audiences.
Leadership.
Communicating and Influencing.
Working Together.
Seeing the Big Picture.
Experience of policy development in a regulatory environment.
Working knowledge of the UK Medical Devices Regulations 2002, with knowledge of the EU Medical Devices Regulation and/or EU in vitro Diagnostic Medical Devices Regulation also desired.
Minimum of a Bachelors degree or equivalent in a scientific, engineering or medical discipline - e.g. physics, chemistry, engineering, life sciences, pharmacy, nursing or medicine.
Equivalent experience will be accepted in place of a degree.
Candidates will be subject to UK immigration requirements as well as Civil Service nationality rules.
Successful candidates must pass a disclosure and barring security check as well as animal rights and pro-life activism checks.
People working with government assets must complete basic personnel security standard checks.
Applicants are assessed on whether they meet any mandatory requirements as well as the necessary skills and experience for the role.
Applications are scored based on the competency-based answers provided.
All examples and statements provided must be truthful, factually accurate and taken directly from your own experience.

Skills

Scientific input
Technical input
Policy input
Guidance development
Regulatory advice
Stakeholder communication
International engagement
Team leadership

Location

10 South Colonnade, Canary Wharf London, E14 4PU

Work Type

Full-time
Fixed term contract
Internal move
Temporary promotion
Loans
Hybrid working
Remote working potentially available

Experience Level

Internal candidates
Employees of accredited non-departmental public bodies (NDPBs)

Education Level

Bachelors degree or equivalent

Benefits

Civil Service Success Profiles used for assessment
Potential for Tax-Free Childcare
Staff joining on promotion will receive up to a 10% increase of their current basic salary, or the pay band minimum, whichever is the greater.
Successful candidates may be subject to annual Occupational Health reviews dependent on role requirements.

About the Company

The Medicines and Healthcare products Regulatory Agency enhance and improve the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research.
The agency is made up of c.1300 staff working across two main centres and peripatetically across the UK and abroad.
The agency consists of Corporate, Digital & Technology, Enablement, Healthcare Quality & Access, Partnerships, Safety & Surveillance and Scientific Research & Innovation.
The Innovation and Compliance (I&C) group delivers public health impact, world-leading research innovation, and a unique proposition via an ambitious Science Strategy which balances innovation against sustainability and affordability.
The Innovative Devices function works to provide pre-market support and facilitates a smooth passage to market access.
This is particularly aimed at innovative products across MedTech, diagnostics and digital, or where there is higher associated risk.
The function will ensure that the UK has supply of new and advancing medical devices to include software as a medical device, novel implantables and diagnostics and play a significant role in developing the new regulatory framework for medical devices, including implementation and operation of specific services.

Equal Opportunity

This vacancy is open to all Civil Service employees and employees of accredited non-departmental public bodies (NDPBs) who were appointed on merit following a fair and open competition; or were appointed to a permanent post through an exception in the Civil Service Commissioners' rules.
In accordance with the Civil Service Commissioners’ Recruitment Principles our recruitment and selection processes are underpinned by the requirement of selection for appointment on the basis of merit by a fair and open competition.