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Civil Service Pension with an average employer contribution of 27%
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About the job
Job summary
We are currently looking for a Head of Approved Bodies and Proactive Market Surveillance to join our Standards & Compliance Team within the Healthcare Quality & Access group.
This is a full-time opportunity, on a permanent basis. The role will be Home Based. Please be aware that this role can only be worked in the UK and not overseas.
Salary arrangements depend on home location with London-based employees receiving London rate of £70,011 for G6 grade.
Please discuss this with the recruiting manager before accepting an appointment.
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 portfolio 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 Standards & Compliance function will enable innovation and healthcare access across the global product lifecycle by risk proportionate standards development and compliance through the British Pharmacopoeia and MHRA Laboratory, the Inspectorate, the Inspection Action Group and Devices Audit and Compliance.
Job description
Whats the role?
This role is responsible for leading, managing and developing the Approved Body and proactive market surveillance unit.
This role will be responsible for the oversight of the designation and monitoring of UK approved bodies. They will also be responsible for manufacturer, economic operator and other international audit programmes.
Key responsibilities:
- Overall responsibility for the operational management of the Approved Body and proactive market surveillance until.
- Lead on liaison with UK approved bodies and industry representatives on matters concerning regulation of audit and associated issues.
- Provision of regulatory advice and guidance regarding the implementation and interpretation of medical device regulation, and associated UK legislation, to both internal and external stakeholders.
- Working with colleagues in other teams to support the programme for developing and implementing new legislation for medical devices.
Person specification
Who are we looking for?
Our successful candidate will:
- Understanding and knowledge of medical device regulations
- Qualified ISO 13485 auditor or other relevant experience of the conformity assessment of medical devices
- Communicating and influencing
- Proven ability to understand and assess impact of policy and regulatory change.
- Working together actively build and maintain a network of colleagues and contacts to achieve progress on shared objectives.
If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification!
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Benefits
£17,890 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 0300 123 6666
- 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
Things you need to know
Selection process details
The selection process:
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.
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 applicants 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
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Working for the Civil Service
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).
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Contact point for applicants
Job contact :
- Name : The Resourcing Team
- Email : Careers@mhra.gov.uk
Recruitment team
- Email : Careers@mhra.gov.uk
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