Website Medicines and Healthcare Products Regulatory Agency
LocationLondonAbout the jobSummaryDevices – Unit Manager, Devices Compliance
We would like to reassure all applicants that we are continuing to recruit through these challenging circumstances. For any vacancies advertised we are proceeding with Video Interviews where possible and are facilitating remote homeworking for all positions where possible. Should you have any queries on the current recruitment process at the MHRA please contact [email protected]
We are currently looking for a well-regarded Unit Manager to join our Devices Division and lead the Devices Compliance unit. This is a full-time opportunity, on a permanent basis.
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 MHRA’s Devices Division is the primary source of expertise within the MHRA and the Department of Health and Social Care for matters relating to safety, quality and performance of medical devices. It is made up of the Regulatory; Safety & Surveillance; Clinical; and Information and Operations Groups.
Following the end of the Transition Period on December 31st, 2020, the MHRA will become a standalone regulator and will face new challenges as the regulatory framework changes.
This role will be critical in ensuring the Agency continues to develop excellent relationships and collaborations with our stakeholders in ensuring medical device on the UK market are safe and performing to the expected standard. The postholder will also be responsible for the implementation of the compliance and enforcement clauses of the Medicines and Medical Device Bill – this role will be the lead on the development of the new enforcement regime that will come in to force as a result of the powers of the Bill.Job descriptionKey responsibilities:
• Lead on the development and implementation of a new enforcement regime, pushing MHRA to the forefront of proactive and proportionate enforcement actions. This will require development of exceptional working relationships across Government, with the legal team, other enforcement Agencies and other key stakeholders in the regulation of medical devices in the UK.
• Lead the compliance team’s contribution to the development of a future regulatory framework, supporting the Agency in setting out its strategy for world leading medical device regulation.
• Support the work to ensure the Medicines and Medical Devices Bill passes through parliament. This role will be instrumental in the Agency’s strategy to bring the powers in to force and build a robust and transparent enforcement strategy.
• Provide support to the Devices SMT and Director on key compliance issues, briefing wider CET/CEO/DHSC and Ministers as required on emerging issues.
• Work with the intelligence unit of IE&S to establish and handle the different threats to the UK’s supply of medical devices and associated public health issues including close liaison with UK Border Force and Trading Standards agencies
ResponsibilitiesOur successful candidate will:
• Have highly developed managerial skills, a proven capable manager and demonstrable team leadership.
• Have expertise in the Devices field and able to provide specialist advice to senior managers, including C suite stakeholders.
• Be experienced in making complex decisions from a range of options and application of judgement to reach the best decision in the circumstances.
• Be experienced in policy development in a regulatory environment
• Have excellent communicating and influencing skills, with the ability to explain complex issues.Benefits• A working environment that supports flexible working options
• 25 days annual leave increasing to 30 with service
• Season ticket loans
• Subsidised gym membership
• Commitment to professional development
• Access to shopping discounts through the ‘Mylifestyle’ employee benefits portal
• Access to learning and development tailored to your role
• A working culture which encourages inclusion and diversity
• A civil service pensionThings you need to knowSecuritySuccessful candidates must pass a disclosure and barring security check.People working with government assets must complete basic personnel security standard checks.Selection process detailsThe Civil Service uses a recruitment framework called Success Profiles. To find out more please click: www.gov.uk/government/publications/success-profiles
• 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.
If you require any disability related adjustments at any point during the process, please contact [email protected] as soon as possible.
Feedback will only be provided if you attend an interview or assessment.Nationality requirementsOpen to UK, Commonwealth and European Economic Area (EEA) and certain non EEA nationals. Further information on whether you are able to apply is available here.Working for the Civil ServiceThe Civil Service Code 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.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. Apply and further information Once this job has closed, the job advert will no longer be available.