Regulatory Affairs Advisor - £36,395 p.a. + benefits

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.
Who are we?
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 their 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, + 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., We use the Civil Service Success Profiles to assess our candidates, find out more here.
+ 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., + 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
Further information on nationality requirements (opens in a new window)

Working for the Civil Service
The Civil Service Code (opens in a new window) sets out the standards of behaviour expected of civil servants.
We recruit by merit on the basis of fair and open competition, as outlined in the Civil Service Commission's recruitment principles (opens in a new window).
The Civil Service embraces diversity and promotes equal opportunities. As such, we run a Disability Confident Scheme (DCS) for candidates with disabilities who meet the minimum selection criteria.
The Civil Service also offers a Redeployment Interview Scheme to civil servants who are at risk of redundancy, and who meet the minimum requirements for the advertised vacancy.

Diversity and Inclusion
The Civil Service is committed to attract, retain and invest in talent wherever it is found. To learn more please see the Civil Service People Plan (opens in a new window) and the Civil Service Diversity and Inclusion Strategy (opens in a new window).

+ 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 in to account the wider landscape.
+ Communicating and Influencing - Excellent communicator; verbal, written and presentational showing positivity and enthusiasm towards work. Able to relay to regulatory, scientific or technical information and convey this accurately to stakeholders, Successful candidates must undergo a criminal record check.
People working with government assets must complete baseline personnel security standard (opens in new window) checks.

Alongside your salary of £36,395, Medicines and Healthcare Products Regulatory Agency contributes £10,543 towards you being a member of the Civil Service Defined Benefit Pension scheme. Find out what benefits a Civil Service Pension provides.
+ Annual Leave: 25 days annual leave on entry, rising by one day for each completed year of service to a maximum of 30 days and pro-rata for part-time staff. PLUS 8 bank holidays
+ Privilege Leave: 1 day
+ Hours of Work: 37 hours (net) per week for full time staff in all geographical locations, including London and pro rata for part-time staff
+ Occupational Sick Pay (OSP): One month full pay/one month half pay on entry, rising by one month for each completed year of service to a maximum of five months full pay/five months half pay
+ Mobility: Mobility clause in contracts allowing staff to be mobile across the Civil Service
+ Civil Service Pension Scheme. Please see the link for further information http://www.civilservicepensionscheme.org.uk/ For enquiries relating to the Civil Service Pension Schemes please contact MyCSP's Pension Service Centre directly on
+ Flexible working to ensure staff maintain a healthy work-life balance
+ Interest free season ticket loan or bike loan
+ Employee Assistance Services and access to the Civil Service Benevolent Fund
+ Eligibility to join the Civil Service Motoring Association (CSMA)
+ Variety of staff and Civil Service clubs
+ On-going learning and development