About the job

Job summary

We are currently looking for an Innovative IVDs and General Medical Devices Lead to join our Innovative Devices Team 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/South Mimms, Hertfordshire. Please be aware that this role can only be worked in the UK and not overseas.  

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 is leading on the development of a new regulatory framework for the UK, which protects patient safety whilst enabling innovation. It also works to improve pre-market support for medical device manufacturers and developers and facilitate a smooth passage to market access through improved regulation and guidance along with tailored support for 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 implantable devices and diagnostics and play a significant role in developing the new Regulatory Framework for Medical Devices.

Job description

• The post holder will lead a team of specialists to ensure that timely and appropriate team leadership and specialist input is provided to the development and implementation of the new medical device regulations to ensure they are fit for purpose, working in collaboration with colleagues across the Agency, in particular in the Partnerships portfolio, Government Legal Department and Department of Health and Social Care.
• This will include Medical Devices Regulation in Northern Ireland, leading interactions with DHSC and external stakeholders on how the MHRA fulfils its regulatory duties in Northern Ireland. 
• The post holder will have a key focus on review and development of a strategy for IVDs and implantable devices, ensuring these products are regulated accordingly to their risk profile and that we clearly address the recommendations in the Independent Medicines and Medical devices safety review (IMMDSR).

Key responsibilities: 

Leadership and management

The post holder will lead a team of up to 10 people, creating a sense of purpose for the team through highlighting connections between our work and the impact on patients and the public. They will provide support, guidance and coaching for the team, show commitment to personal development, promoting effective individual and team performance. They will lead and drive a complex activities with competing priorities with multiple partners and stakeholders and delivering at pace. They will provide insight and leadership to achieve the MHRA’s business plan and corporate objectives.

Service delivery

The post holder will be the senior lead for the Coronavirus Test Devices Approvals (CDTA) process, responsible for delivery under the current scheme including financial management, as well as supporting the Head of IVDs and General Medical Devices to design and implement sustainable arrangements for Coronavirus testing.

 The post holder and their team will also own deliverables in the Med Tech Regulatory Reform plan and be accountable for on time delivery, as well as supporting the Head of IVDs and General Medical Devices in the development of strategic approaches for IVDs and implantable devices including Neurotech, in line with the response to the Independent Medicines and Medical Devices Safety Review (IMMDSR).

 

Person specification

Have a strong and inclusive corporate and team leader qualities, confident in both people leadership and policy development.

• The role will require highly developed interpersonal and influencing skills and the credibility to build excellent relationships and networks with key stakeholders across organisational boundaries, taking a collaborative approach.
• The successful applicant will need to be a flexible and adaptable leader with the ability to support, guidance and coaching others through change whilst maintaining strong governance and processes.
• Experience in developing and implementing policy in a complex environment involving a wide range of stakeholders is required.
• The ideal candidate would have operational experience working in a regulatory environment and in healthcare at a policy, operational or front-line level, preferably experience of working with Medical Device Regulations or IVD regulations in the UK or EU and a strong understanding of compliance with statutory and regulatory frameworks.

 

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 £70,011, Medicines and Healthcare Products Regulatory Agency contributes £20,282 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 a statement of suitability, attached as a PDF of no more 750 demonstrating how you meet the person specification. 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.Please ensure not to include any personal identifying information on your supporting information.
• 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 statement of suitability provided. You can view the criteria for this role in the job description.

Use of AI in Job Applications:

Applicants must ensure that anything submitted must be 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: 2nd September 2024

Shortlisting date: 6th September 2024

Interview date: 25th September 2024

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 

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.