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Regulatory Affairs Specialist

Posted: 9 May 2022 Closes: 30 May 2022
Leeds or London Band 7 - £40,057 - £45,839
Permanent & Full-time 214413658

About the role

Where you make a difference

NHS Digital is the national digital, data and technology partner for the NHS and social care system. We design, build, deploy and operate national products, platforms and data services for patients, clinicians, those who manage the system and researchers in the NHS, academia and the life sciences sector. Our systems serve up to 53 million citizens and 1.3 million NHS staff.

Our goal is to maximise the accessibility, quality and utility of health and care data while respecting privacy, transparency and ethics. As such we are responsible for analysing large volumes of data related to topics such as hospital care, social care, mental health, diabetes, maternity and weight management. We interpret the trends within this data, summarise the results within dashboards and publications and make data available for further research. All of which supports the policy decisions made within the health and social care system.

The Medical Device Directive Programme (MDD), part of the Assurance and Risk Management Directorate, facilitate regulatory affairs and quality compliance activities necessary for legally making medical devices available to users and the public. NHS Digital are the registered legal manufacturer of various stand-alone software as a medical device tools and platforms, which support key NHS frontline services such as urgent and emergency care, NHS.UK website and the COVID-19 response and living with covid strategy, with new developments in the pipeline.

What's involved, top line

The MDD Programme works closely with product delivery teams to provide support with regulatory and quality compliance activities and implements a quality management system suitable for the design, development, and manufacturer for medical devices. The MDD Programme will also prepare the organisation for changes in the regulatory landscape.

More about the role

Here at NHS Digital, we are growing and investing in our Regulatory Affairs team. We are recruiting for a permanent Regulatory Affairs Specialist to support the Regulatory Affairs and Quality Compliance Manager in compliance activities relating to stand-alone software as a medical device. This is a new role for NHS Digital.

This is an excellent opportunity for a Regulatory Affairs Professional to move into a niche and emerging area of regulation as well as working within the public sector, with excellent support, learning and development opportunities.

You will be supporting the Regulatory Affairs and Quality Compliance Manager with 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 executive level.

You will:
  • Support implementation of the quality and regulatory strategy for software as a medical device at NHS Digital in line with the UK MDR 2002
  • Assist and support in the maintaining compliance with the current and future medical device regulations in the UK and applicable standards and guidance
  • Work with product teams in the creation, maintenance, and update of technical documentation and associated documentation
  • Keep up to date of and support in the implementation of future regulatory changes in the UK
  • Support in the application and/or renewal of conformity registrations, some of which may be difficult and complex
  • Provide support to the regulatory team members and wider product teams
  • Support the Regulatory Affairs and Quality Compliance Manager during internal/external audits and corrective action planning, as required.
  • Support the investigation of quality issues, customer complaints or product failure, with both internal and external stakeholders to a successful resolution
  • Support in the reporting of incidents, adverse trends and field safety corrective action
  • Review product labelling and supporting materials to ensure compliance with the applicable regulatory requirements
  • Promote awareness of the regulatory UK MDR QMS requirements throughout the organisation.

About you

Below are some of the key skills and experience we're looking for. Please note that these will be used in shortlisting candidates for interview so please ensure your supporting statement includes specific examples on how you meet the criteria for each of these.

  • Experience in the completion of compliance and conformity activities for medical devices with internal and external customers, suppliers, and outsourced services.
  • Professional experience in regulatory affairs and quality management systems relating to medical devices
  • Experience in providing expert guidance to all levels of staff in the application of medical device regulations and standards
  • Experience of identifying and monitoring of risk with medical device software and software apps in line with ISO 14971
  • Experience of working with key stakeholders to implement appropriate corrective and preventive actions and address nonconformities
  • Experience of identifying trends and relationships from medical device compliance and conformity activities and recommend improvement initiatives
  • Experience of reporting incidents and adverse trends to external bodies: MHRA as the UK medical device regulatory body and approved bodies
  • Knowledge and application of UK MDR (2002)/MDD 93/42/EEC, including post market surveillance activities
  • Knowledge of processes undertaken for conformity assessment and declaration of conformity
  • Knowledge and application of ISO 13485:2016 (Quality Management Systems for Medical Devices) and other applicable standards.
  • Knowledge of UKCA/CE marking of Class I, IIa, IIb of software as a medical device under the UK MDR and specific applicable standards e.g. IEC 62304 (advantageous)
What's in it for you

  • A role as part of a dynamic team using data and digital technology to transform health and care
  • A range of opportunities to build your experience in an environment where your work has a direct and positive impact
  • A real commitment to your personal and professional development with access to a broad range of learning opportunities

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, so 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:

Find further information on the current work we are undertaking meeting the challenges of the pandemic here:

Why you should apply

We value the different experiences our people bring to their work at NHS Digital. We're working to create an environment where everyone can make a full contribution no matter their background, identity, or circumstances.

Which means, we encourage applications from people of all backgrounds and abilities. Don't worry if you don't meet all the criteria we've suggested - knowledge and experience you've gained in other ways might make us think about the role differently. Go ahead and apply.

Our work matters. You matter.

What we offer you:
  • we're moving to a hybrid working approach which offers you an informal, flexible way of blending home and office working
  • flexible working opportunities - we value and respect the diversity of our employees, and applications from prospective candidates who require flexible working arrangements are welcomed; these include part-time hours, job sharing, flexible hours and part-remote set ups
  • 27 days annual leave increasing to 33 days with service
  • ability to buy and sell annual leave
  • a generous pension (with our contribution equal to 20.6% of your earnings)
  • NHS Discounts including shops, restaurants, gym, mobile phones, and insurance
  • employee benefit schemes including our Season Ticket Loan, Car Lease and Bike to Work schemes

Next steps

Remote interviews will take place late may/early June 2022. Applicants selected for interview will be contacted by email.

To view further information please see the attached role profile and to apply for the role click 'Apply for job' below.

Please ensure your supporting statement includes demonstrable evidence and specific examples on how you meet the criteria for each of the key skills and experience specified above. Pleaser remove any personal details to allow for your application to be reviewed anonymously.

This post is not exempt from the Rehabilitation of Offenders Act 1974. We only ask applicants to disclose convictions which are not yet spent / unspent under the Rehabilitation of Offenders Act 1974. Following an offer of employment, we will carry out a Basic Disclosure and Barring Service (DBS) check as part of the pre-employment check process.
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