Regulatory Affairs Specialist

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.

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:

• 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)

• 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