Regulatory Affairs Advisor

Who are we?

The Medicines and Healthcare products Regulatory Agency enhance and improve the health of millions of people through the effective regulation of medicines and medical devices.

What's the role?

This role is responsible for handling clinical investigation applications, providing regulatory advice to stakeholders, and supporting the team in the implementation of regulatory changes. You are expected to develop sound judgement when issues arise, particularly in the assessment of clinical investigation applications.

Key responsibilities

• Act as the regulatory handler for individual clinical investigation applications from manufacturers wishing to undertake clinical investigations in the UK with non CE or non UKCA marked Medical Devices.
• Provide regulatory advice regarding the implementation and interpretation of the current and future EU medical devices regulatory framework and associated UK legislation, with a particular focus on Clinical Investigations.
• Participate in necessary projects and work with the team leading on the implementation of the new medical device and in vitro diagnostic medical device regulations.
• Assist in ensuring that guidance documents, website information and internal procedures are up to date.

Who are we looking for?

Successful candidates will have:

• A degree in a relevant discipline e.g. physics, chemistry, engineering, life sciences, pharmacy, nursing or medicine.
• Ability to analyse data.
• Excellent communication skills.
• Ability to work at pace.
• Ability to work under pressure.

Person Specification

Method of assessment: A=Application, I=Interview

Behaviour Criteria

• Changing and Improving (A, I)
• Communicating and Influencing (I)
• Working Together (A)
• Delivering at Pace (I)

Experience Criteria

• Proven ability to analyse and interpret a variety of evidence / data and draw key conclusions, taking into account the wider landscape (A, I)
• Demonstrate how a new process or programme of work has been successfully planned and implemented (I)

Technical Criteria

• A degree in physics, chemistry, engineering, life sciences, nursing or medicine (A)
• Knowledge of regulation and guidance on clinical investigations of Medical Devices. Awareness of the regulation of clinical trials of medicines (A, I)

Strengths Criteria

• Adaptable (I)
• Relationship Builder (I)

Adjustments for disability

If you require any disability related adjustments at any point during the process, please contact as soon as possible.

Additional Information

Closing date: 19th January. Shortlisting date: 16th February. Interview date: from 23rd February.

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.

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.

Use of AI in Job Applications

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, 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.