Regulatory Affairs Specialist

NHS England

This job is now closed

Job summary

An opportunity has arisen for a regulatory specialist to join the patient safety team as part of the Transformation Directorate's Digital Clinical Informatics (DCI) team.

The role supports the quality and regulatory team in implementing and maintaining NHS-England's quality management system in compliance with ISO 13485 and in regulatory activities for NHS England's software medical device products (SaMDs). Crucial national impact products such as 111 online and Pathways (underpinning 999 service) form part of this portfolio.

Our team support NHS England to deliver products and services that are safe, effective and of value to patients, citizens, and frontline staff, and that ultimately lead to better outcomes including improved health and wellbeing. We are responsible for providing strategic leadership to NHS England, and ensuring our organisational activity aligns with, and supports, wider health and care strategy while addressing health and social inequalities.

We apply robust quality and regulatory governance and oversight to ensure all products that qualify as Software medial devices are developed, deployed and maintained as per the relevant regulatory requirements.Our team continues to grow to ensure that we can meet all programme needs. This is an exciting role with responsibility for providing support to multiple internal programmes which are developing SaMDs.

Main duties of the job

Some of the skills and experience we're looking for:

Bachelor degree with 2 years experience in QA/RA in the medical device industry
Good understanding of ISO 13485 and UK MDR 2002
Cross-functional, risk-based and innovative thinking skills
Accurate and punctual attitude
Good presentation and communication skills
Good knowledge of English (written and spoken)
Team-player
Ideally hands on experience in QA/RA for software medical device
Ideally experience of performing audits

About us

The NHS England board have set out the top-level purpose for the new organisation to lead the NHS in England to deliver high-quality services for all, which will inform the detailed design work and we will achieve this purpose by:

Enabling local systems and providers to improve the health of their people and patients and reduce health inequalities.
Making the NHS a great place to work, where our people can make a difference and achieve their potential.
Working collaboratively to ensure our healthcare workforce has the right knowledge, skills, values and behaviours to deliver accessible, compassionate care
Optimising the use of digital technology, research, and innovation
Delivering value for money.

If you would like to know more or require further information, please visithttps://www.england.nhs.uk/.

Colleagues with a contractual office base are expected to spend, on average, at least 40% of their time working in-person.

Staff recruited from outside the NHS will usually be appointed at the bottom of the pay band.

NHS England hold a Sponsor Licence; this means that we may be able to sponsor you providing the Home Office requirements are met. To be eligible for sponsorship through the Skilled Worker route you'll usually need to be paid the 'standard' salary rate of at least £38,700 per year, or the 'going rate' for your job, whichever is higher. You can find more information on the Government website.

Date posted

09 October 2024

Pay scheme

Agenda for change

Band

Band 7

Salary

£46,148 to £52,809 a year (exclusive of London weighting)

Contract

Permanent

Working pattern

Full-time

Reference number

990-TD-CTDCI-6579199-E

Job locations

NHS England Office in London / Leeds

London / Leeds

LS1 4AP

Job description

Job responsibilities

Our outstanding teams are passionate about technology and public service, making use of everyones skills to improve peoples 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.

You can find further details about the job, in the attached Job Description and other supporting documents.

Job description

Job responsibilities

You can find further details about the job, in the attached Job Description and other supporting documents.

Person Specification

Qualifications

Essential

Educated to masters level in relevant subject or equivalent level of experience of working at a senior level in specialist area.

Experience and Knowledge

Essential

Experience in Quality Management Systems for Medical Devices
Risk Management

Desirable

Audits

Skills Capabilities & Attributes

Essential

Strategic thinking

Person Specification

Qualifications

Essential

Educated to masters level in relevant subject or equivalent level of experience of working at a senior level in specialist area.

Experience and Knowledge

Essential

Experience in Quality Management Systems for Medical Devices
Risk Management

Desirable

Audits

Skills Capabilities & Attributes

Essential

Strategic thinking

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).

Additional information