About the job

Job summary

We are currently looking for a Diagnostics Specialist to join our Innovative Devices function within the Healthcare Quality and Access 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 4 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 8 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 Innovative Devices function works in collaboration with the Approved Bodies to provide pre-market support and facilitates a smooth passage to market access. This is particularly aimed at innovative products across med-tech, 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 In Vitro Diagnostics (IVDs) and play a significant role in developing the new Regulatory Framework for Medical Devices.

 

Job description

What’s the role?

The Diagnostics Specialist will lead and manage the development and implementation of Diagnostics Regulations and will support engagement and partnership working with senior external stakeholders, government departments, professional bodies and the wider health sector to ensure UK patients have access to safe and effective innovative Diagnostics.

 

 Key responsibilities: 

• Lead a significant work programme to increase focus on the importance of safer and effective Diagnostics devices.
• Provide scientific, technical and policy capacity to inform regulatory decision making and towards use cases in partnership with stakeholders as required.
• Contribute significantly on the development of external partnerships with key external stakeholders such as patients and the public, NICE, National Quality Assurance Schemes, Royal College of Pathologists and emerging health organisations.

Provide scientific, technical and policy input to independent expert advisory committees as required.
 

Person specification

Our successful candidate will: 

• Masters degree or equivalent in a scientific, engineering or medical discipline.
• At least 2 years prior experience in policy, advisory or product development.
• Prior experience with manufacturing and/or research and development of a medical device.
• Detailed understanding of UK MDR, EU IVDR and UK MDR
• Prior experience leading technical aspects of regulatory or clinical
• Competence communicating with audiences of 10+ people
   
  If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification! 

Please note: The job description may not open in some internet browsers. Please use Chrome or Microsoft Edge. If you have any issue viewing the job description, please contact careers@mhra.gov.uk 

Benefits

Alongside your salary of £56,353, Medicines and Healthcare Products Regulatory Agency contributes £15,215 towards you being a member of the Civil Service Defined Benefit Pension scheme. Find out what benefits a Civil Service Pension provides.

Things you need to know

Selection process details

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. 
• Presentation, to be prepared as part of your interview, with further information being supplied when you reach this stage.
  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. 

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: 30th March 2024
Interview date: 8/9th April 2024

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, 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 

Feedback will only be provided if you attend an interview or assessment.

Security

Successful candidates must undergo a criminal record check. People working with government assets must complete baseline personnel security standard (opens in new window) checks.

Nationality requirements

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

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.