About the job

Job summary

We are currently looking for a Senior Medical Device Specialist to join our Software team within the Healthcare, Quality & Access group

This is a full-time opportunity, on a fixed term contract/internal move or temporary promotion basis until 31 March 2025. 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 objective of the Healthcare, Quality and Access group is to drive quality and critically appraise benefits and risks to inform robust decisions on healthcare access including accelerated access pathways. It will do this by bringing together a fusion of our capabilities across both medicines and medical devices to enable licensing and market access, as well as ensuring compliance with regulations and standards.

The Software team is responsible for taking all reasonable steps to protect the public health and safeguard the interests of patients by ensuring that software as a medical device meet all appropriate standards of safety and performance and to encourage safe use. The team does this by providing technical support and advice to the Innovative Devices Regulatory Policy Group; contributes to the review of clinical investigations and compliance activity; and engages with internal and external stakeholders on a range of issues involving software as a medical device. Following the UK exit from the EU, the Software team is now leading on the development of a new regulatory framework for software as a medical device

Job description

What’s the role?

The core purpose of this role is to provide technical and regulatory support to the Software team and wider across other teams in the MHRA. The post holder will have the responsibility to make timely and robust benefit-risk decisions on software medical devices with actions that are outcome focussed. The post includes provision of written advice and guidance to internal and external enquiries on the current medical device regulations, including general enquiries, input into FOI requests, parliamentary cases and the provision of briefings to senior officials and Ministers as required.

Key responsibilities: 

 

• Work in matrix way, leading and/or contributing to ensure delivery of Agency objectives on issues relating to software as a medical device, its use and regulation and to help implement regulatory change as the regulations evolve.
• Effective management of risk management reports (risk analysis, risk control and risk evaluation) to ensure robust and timely regulatory decisions

• Provide authoritative up to date regulatory guidance in writing and orally to relevant stakeholders. 
• Represent the Agency at advisory and external meetings, addressing high profile issues and topical issues to provide authoritative up to date advice and regulatory positions. 

Person specification

Our successful candidate will: 

-          Have a Degree or equivalent qualification in a health care, regulatory or health data science/analytics (such as medical engineering, material science, or healthcare qualification) or previous relevant experience gained in healthcare, medical device manufacturing, regulatory environment, or health data science.

 

-          Have a proven ability to communicate (written and oral) effectively to maintain positive working relationships with stakeholders.

 

-          Display confidence when making difficult decisions, even if they prove to be unpopular. Consult with others to ensure the potential impact on patients/end users have been considered.

 

-          Gain a clear understanding of customer’s needs and expectations.  Act to prevent problems and provide solutions.

 

-          Have a proven understanding of risk management principles to reduce harm (direct or indirect) and a proven ability to manage complex projects to agreed milestones and managing conflicting priorities and the work of others.

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 £42,869, Medicines and Healthcare Products Regulatory Agency contributes £11,574 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. 
• 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: 11th March

Shortlisting date: 15th March

Interview date: 27th March

 

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 

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.