The Assurance and Risk Management Directorate at NHS Digital are looking for a Regulatory Affairs and Quality Compliance Manager with experience in software as a medical device.  This is a new role for NHS Digital.

You will be responsible for ensuring all activities relating to regulatory and quality compliance for NHS Digital’s medical device software and software apps are met.  You should therefore have knowledge and understanding of the digital health environment and healthcare industry.

This role requires strong communication and interpersonal skills as you will work with internal and external stakeholders up to chief executive level. You must therefore have a proven track record in senior leadership and management roles.

As the Regulatory Affairs and Quality Compliance Manager:

You will need a substantial and proven track record in medical device regulation and regulatory affairs, specifically for software and software apps, under the UK Medical Devices Regulations 2002 (UK MDR 2002).

You will:

• Develop and implement a medical device regulatory and quality management strategy across NHS Digital, taking into account future regulatory changes in the UK
• Carry out conformity assessments and declarations of conformity
• Develop and implement medical device regulatory and quality policies, processes, and procedures
• Manage and maintain NHS Digital’s medical device regulatory system, including technical files
• Identify and monitor risks with medical device software and software apps in line with ISO 14971
• Develop, review and approve medical device labelling, product and process changes
• Work with the internal quality management audit team in the delivery of internal and external audits, including with Approved Bodies and the MHRA
• Provide support on design and process verification to teams developing software and software apps
• Ensure all regulatory reporting obligations are met as part of NHS Digital’s post-market surveillance activities
• Provide oversight and assistance in clinical evaluation reports

You will represent NHS Digital at meetings with external stakeholders, including regulatory agencies, Arm’s-length bodies, third-party manufacturers and other healthcare organisations. You must have significant experience of communicating with healthcare organisations, regulatory agencies (e.g. MHRA) and UK Approved Bodies.

About You

You will need to have up-to-date and working knowledge of the following:

• UK MDR 2002
• ISO 13485, ISO 14971, ISO 14155 and EN ISO 62304
• IEC 62366-1
• Good Manufacturing Practices (GMP) and how it applies to medical devices

You must demonstrate the following:

• willingness to take responsibility and successfully drive medical device activities
• proven leadership and stakeholder management experience at a senior level
• capacity to work effectively, both independently and as part of a team
• have a structured and methodical approach
• have a drive for improvement

Qualifications

• You must have a degree in a scientific discipline, engineering, law or medicine.
• A post-graduate qualification in a scientific discipline, medical device regulatory affairs, engineering, law or medicine would be an advantage.

About Us

NHS Digital is a great place to work. What we do matters.

Our outstanding teams are passionate about technology and public service, making use of everyone’s skills to improve people’s lives.

We collaborate to deliver world class tech and intelligence, come and join us. We are committed to sustainability, diversity and inclusion; our people are at the heart of what we do.

Find out about the amazing work we do by visiting our website: https://digital.nhs.uk/about-nhs-digital/our-work

Find further information on the current work we are undertaking meeting the challenges of the pandemic here: https://digital.nhs.uk/coronavirus

What we offer

In addition to a competitive salary with planned, transparent progression you can look forward to the following benefits:

• 27 days annual leave entitlement increasing with service
• Buy and sell annual leave scheme
• Contributory Pension (with a 20.6% contribution from us toward the cost of your pension)
• Flexible working opportunities - we value and respect the diversity of our employees, and applications from prospective candidates who require flexible working arrangements are welcomed
• A range of NHS Discounts covering, for example, shops, restaurants, gym, mobile phones and insurance
• Employee benefit schemes which include Season Ticket Loan and Car Lease

For more information visit our Working at NHS Digital page.

Next Steps

Applicants who are shortlisted will be invited to interview by email. Remote interviews are currently scheduled to take place week commencing 10th of May.

To view further information please see role profile, to apply for the role click apply, below.

NHS Digital values and respects the diversity of prospective candidates and aims to recruit a workforce which reflects this, with that in mind candidates requiring flexible working hours will be considered. 

We are unable to accept speculative CVs, all applications must be made through NHS Digital’s career site.