Senior Compliance Manager

Full Time
  • Full Time
  • London
  • Salary: £49,351

Website Medicines and Healthcare products Regulatory Agency

Devices – Senior Compliance Manager

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 Senior Compliance Manager to join our Device Compliance Unit within the Devices Division. 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.

The role will be a key support for the Unit Manager and will be required to undertake deputy duties as necessary. The post holder will provide the lead on the functional management of the compliance team, supporting the day to day investigations and operational work undertaken by the team. There will be a focus on continuous improvement, ensuring that the approach taken by the MHRA reflects best practice in line with Government guidelines.

Key responsibilities:

Lead the devices compliance activities within the Devices Regulatory Group, ensuring all allegations of device non-compliance are investigated, closed and escalated as necessary to defined timeframes.Support the ongoing work to develop a new proactive compliance work programme, which puts in place an evidence-based mechanism to identify at-risk products or product categories for further investigation.Support the Unit Manager and represent the agency on wider government initiatives and collaboration on international operations to ensure a safe UK supply chain for medical devices.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.Management and operational development of the devices case referral unit for non-compliant and counterfeit devices including appropriate standard operating procedures and optimization of risk assessment process.
Our successful candidate will:

Have extensive knowledge and understanding of product compliance & enforcement gained in the industrial arena and ability to demonstrate capability.Be an excellent communicator, with the ability to influence, instil confidence and build trust in others.Have expert knowledge and understanding of the Medical Device RegulationsBe able to facilitate the delivery of business objectives through active development and maintenance of a key network of stakeholdersHave excellent planning and organisational skills.

If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification!

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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.

If you require any disability related adjustments at any point during the process, please contact [email protected] as soon as possible.

If you need assistance applying for this role or have any other questions, please contact [email protected]

Candidates will be subject to UK immigration requirements as well as Civil Service nationality rules.

Our process requires that you apply through our careers site, where you will be asked to complete your application and answer some competency based questions. Applicants are assessed on whether they meet any mandatory requirements as well as the necessary skills and experience for the role. Applicants are scored on their competency answers so please ensure you have read these thoroughly and allow sufficient time. You can view the competencies for this role in the job description.

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, [email protected]

If you are not satisfied with the response you receive, you can contact the Civil Service Commission at: civilservicecommission.independent.gov.uk

[email protected]
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