Regulatory Affairs Advisor

We are currently looking for a Regulatory Affairs Advisor to join our Clinical Investigations Team within the Science, Research & Innovation group. This is a full-time opportunity, on a permanent basis. The role will be based in 10 South Colonnade, Canary Wharf London, E14 4PU. Please be aware that this role can only be worked in the UK and not overseas. Government departments and agencies are working towards implementing a minimum 60% attendance in office sites. We are currently implementing a flexible, hybrid way of working, with a minimum of 8 days per month working on site to enable the collaboration and contact with partners and stakeholders needed to deliver MHRA business. Attendance on site is driven by business needs so depending on the nature of the role, this can flex up to 12 days a month, with the remainder of time worked either remotely or in the office. Some roles will need to be on site more regularly.

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 Science, Research and Innovation Group delivers public health impact, world-leading research innovation, and a unique proposition via an ambitious Science Strategy which will balance innovation against sustainability and affordability. It is divided into 6 sub-Groups: Innovation Accelerator, Clinical Investigations and Trials, Research and Development, Standards Lifecycle, Control Testing and Quality Assurance, and Health & Safety.

This role is responsible for handling clinical investigation applications, providing regulatory advice to our stakeholders and supporting the team in implementation of regulatory changes. You will be expected to develop and display sound judgement of when issues are arising, particularly within the assessment of clinical investigation applications. You will be required to work flexibly and provide support to other teams within the Agency, there will be need for support and advice on applications through the access pathways in Healthcare Quality & Access Group. This provides further opportunity for you to develop your knowledge and understanding whilst further expanding your skill set. You will support the Head of Clinical Investigations in contributing to the development of the future regulatory framework and ensuring the implementation of the new ways of working is done efficiently and is clearly communicated to applicants and key CI stakeholders.

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.
• Assist in ensuring that guidance documents, website information and internal procedures are up to date.
• Provision of 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.
• Assist in resolving borderline interpretations relating to the current and the new medical device regulations and to participate in the resolution of classification and borderline issues which are raised either externally or internally providing support to Borderlines colleagues within Healthcare Quality & Access.
• Take part in the necessary projects and work with the team leading on the implementation of the new medical device and in vitro diagnostic medical device regulations.

Who are we looking for?

Our successful candidate will have:

• A degree in a relevant discipline e.g. physics, chemistry, engineering, life sciences, pharmacy, nursing or medicine.
• Knowledge of regulation and guidance on clinical investigations of Medical Devices.
• Awareness of the regulation of clinical trials of medicines.
• Proven experience in analysing and interpreting a variety of evidence/data and drawing key conclusions, taking into account the wider landscape.
• Excellent communicator; verbal, written and presentational showing positivity and enthusiasm towards work. Able to relay regulatory, scientific or technical information and convey this accurately to stakeholders.

If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification!

The selection process:

We use the Civil Service Success Profiles to assess our candidates. Online application form, including questions based on the Behaviour, Experience and Technical Success Profiles. Please ensure all application questions are completed in full; your application may not be considered if any responses are left blank. Our applications are CV blind, and our Hiring Managers will not be able to access your CV when reviewing your application. Interview, which can include questions based on the Behaviour, Experience, Technical and Strengths Success Profiles. 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- ensure you have read these thoroughly and allow sufficient time. You can view the competencies for this role in the job description.

Use of AI in Job Applications: Applicants must ensure that anything submitted is factually accurate and truthful. Plagiarism can include presenting the ideas and experience of others, or generated by artificial intelligence, as your own. If you require any disability-related adjustments at any point during the process, please contact careers@mhra.gov.uk as soon as possible.

Closing date: 12 January 2025

Shortlisting date: W/C 13 January 2025

Interview date: 22 and 24 January 2025

Candidates will be contacted within a week of the sift and the interviews completed to inform them of the outcome. If you need assistance applying for this role or have any other questions, please contact careers@mhra.gov.uk. Candidates will be subject to UK immigration requirements as well as Civil Service nationality rules. Further information on whether you are able to apply is available here. 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 who are successful at interview will be, as part of pre-employment screening, subject to a check on the Internal Fraud Database (IFD). This check will provide information about employees who have been dismissed for fraud or dishonesty offences. This check also applies to employees who resign or otherwise leave before being dismissed for fraud or dishonesty had their employment continued. Any applicant’s details held on the IFD will be refused employment. A candidate is not eligible to apply for a role within the Civil Service if the application is made within a 5 year period following a dismissal for carrying out internal fraud against government. Any move to the MHRA from another employer will mean you can no longer access childcare vouchers. This includes moves between government departments. You may however be eligible for other government schemes, including Tax-Free Childcare. Determine your eligibility here. Successful candidates may be subject to annual Occupational Health reviews dependent on role requirements. If you have any queries, please contact careers@mhra.gov.uk.

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. If you feel your application has not been treated in accordance with the Recruitment Principles and you wish to make a complaint, you should firstly contact Mira Mepa, Head of Recruitment and Operations, Mira.Mepa@mhra.gov.uk. If you are not satisfied with the response you receive, you can contact the Civil Service Commission at: civilservicecommission.independent.gov.uk info@csc.gov.uk Civil Service Commission Room G/8 1 Horse Guards Road London SW1A 2HQ