Regulatory Affairs Specialist | NHS England
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.
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
- 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 visit https://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 theGovernment website.
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.
You can find further details about the job, in the attached Job Description and other supporting documents.
This advert closes on Wednesday 23 Oct 2024