Expert Auditor - £71,835 - £81,090 p.a. + benefits

Job summary

We are currently looking for an Expert Auditor to join our Devices Compliance and Audit Functionwithin the Innovation and Compliancegroup.

This is a full-time opportunity, on a permanent basis. The role is a homebased role but will require occasional travel to 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 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 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 Compliance Teams, the Inspection Action Group and Devices Audit and Compliance.

Job description

What’s the role?

The expert auditor will perform a crucial role in developing the agency’s medical device audit strategies & legislation, providing technical leadership, guidance and support to the Devices Compliance & Audit Team. They will achieve this through engagement with industry, government and regulatory partners at a national and international level, influencing the global approach to medical device auditing and development of audit practices.

Key responsibilities:

• To lead the work relating to MHRA becoming a full member of the MDSAP programme, taking account of technical, policy and regulatory issues. Working with key stakeholders across the agency to ensure MHRA’s application is successful. They will then act as the technical lead for MDSAP for the agency.

• To lead Devices audit horizon scanning activities, provide advice on the required team direction to prepare for emerging developments.

• To lead the development of the Devices audit strategy and inspection models linking Agency and Government priorities to the work of the Devices Compliance and Audit Team.

• providing sound technical leadership and support, mentorship and guidance to auditors and Inspectors in the Devices Compliance & Audit Teams, as well as technical specialist based in other teams.

Who are we looking for?

Our successful candidate will have the following:

• Changing and Improving - Challenge the way things have always been done and suggest improvements, learning from experience. Encourage measured risk taking and innovation to deliver better approaches and services. Implement changes that transform flexibility, responsiveness and quality of service. Ensure changes add value to the business and express clearly how and why changes are necessary.

• Seeing the Big Picture - Create joined up strategies that put into practice and support the Government’s vision for the future. Identify and shape how your work area fits within and supports the priorities of the organisation.

• Communicating and Influencing - Communicate with others in a clear, honest and enthusiastic way in order to build trust. Explain complex issues in a way that is easy to understand. Take into account people’s individual needs. Deliver difficult messages with clarity and sensitivity, being persuasive when required.

• Extensive knowledge of Medical Device Regulations and industry practice coupled with a broad understanding of the work of the Devices Compliance & Audit Team and the MHRA.

• Proven track record of undertaking medical device audits. Experience of MDSAP audits is desirable

Person specification

Method of assessment: A=Application, T=Test, I=Interview, P=Presentation

Behaviour Criteria:

• Changing and Improving (A, I, P)
• Leadership (A, I, P)
• Seeing the Big Picture (A, I, P)
• Communicating and Influencing (A, I, P)
• Making Effective Decisions (A, I)
• Developing Self and Others (A, I)

Experience Criteria:

• Extensive knowledge of Medical Device Regulations and industry practice coupled with a broad understanding of the work of the Devices Compliance & Audit Team and the MHRA. (A, I, P)

• Proven track record of undertaking medical device audits. Experience of MDSAP audits is desirable (A, I)

• A breadth of understanding and practical experience of modern concepts and practicalities underlying audit for the purpose of medical device regulations (A, I)

Technical Criteria:

• Educated to degree level in a relevant discipline or equivalent experience developed through previous roles. (A, I)

• Good verbal and numerical reasoning skills to allow the analysis and interpretation of written and numerical data. (A, I)

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

Alongside your salary of £71,835, Medicines and Healthcare Products Regulatory Agency contributes £20,810 towards you being a member of the Civil Service Defined Benefit Pension scheme. Find out what benefits a Civil Service Pension provides (opens in a new window).

• 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 [phone removed]
• Flexible working to ensure staff maintain a healthy work-life balance
• Interest free season ticket loan