Regulatory Affairs Manager

NHS; Filton; Hybrid; GBP 50,000 - 70,000; Full time

Job summary

A national healthcare organization in the UK seeks a professional to lead on the implications of EU regulations in blood and tissue services. This role involves collaborating with health departments and ensuring compliance with quality standards. Candidates should have a degree and relevant postgraduate qualifications, along with substantial experience in quality systems and leadership. A hybrid work option is available.

Qualifications

• At least degree level education plus relevant experience.
• Masters qualification or equivalent specialist knowledge is essential.
• Commitment to professional development is necessary.

Responsibilities

• Lead on the implications of EU SoHO Regulation.
• Collaborate with regulators and health departments.
• Prepare and present advice and briefings.

Skills

Quality Systems knowledge

Leadership

Report writing

IT skills with Microsoft Office

Education

Degree plus post graduate diploma or equivalent

Masters level qualification or equivalent knowledge

Job description

You’ll be joining a small team responsible for providing professional guidance to the four UK Blood Transfusion and Tissue Transplantation Services. In this role you will lead on understanding and acting upon the implications of the EU Regulation on Substances of Human Origin (2024/1938) on legislation in Great Britain and Northern Ireland. You will collaborate with colleagues in all four national services and departments of health, and will liaise with regulators - MHRA, HTA and CQC.

Note: This role does provide a hybrid‑working option. You will be assigned a base location which could be one of NHSBT main centres/blood centres, which will be confirmed after the final interview and mutually agreed upon with the line manager during the verbal offer stage.

Main duties of the job

In this role you will be responsible as the lead for UK Blood Transfusion and Tissue Transplantation Services on the impact and implications of the EU SoHO Regulation. Your responsibilities will include:

• Collaborating with regulators and departments of health in the devolved administrations on the interpretation and implications for the services.
• Engaging with collaborators in Europe, including in the Council of Europe, European Blood Alliance and others.
• Preparing and presenting advice and briefings on recommended actions.
• Working with the Directors of Quality in the UK services in their roles of Responsible Person and Designated Individual and the Chief Executives as licence holder to ensure maintenance of licence.

You will be required to travel and spend time away from base, which will involve working irregular hours and overnight stays when required, with prior notice.

About us

It takes all types of people to deliver the kind of service that saves and improves lives. At NHS Blood and Transplant, youll join a team of more than 6,000 people who are making a genuine difference to communities, families, friends, relatives and more across the UK. We play a unique and special role in the NHS by helping people do something extraordinary- donate blood, blood products, organs, tissues, or stem cells to save someone in need.

Our three core values are what set us apart. They guide and inspire everything we do. By being caring, expertly meeting the needs of our patients and our people, and accepting nothing less than the best quality, we can do extraordinary work and help our people to do something extraordinary in their career, too. Three small words, one big difference - Caring, Expert and Quality. Together we’ll save and improve more lives than ever. You will join us on our journey to create an inclusive workplace and aim to reflect the diverse communities we work with, and we positively encourage applications from all sectors of the community.

Job responsibilities

To learn more, please see our recruitment profile, which provides a summary of the job description and person specification. This can be accessed via the link below, or by clicking ‘Apply’ if you are viewing this advert on another site.

Person Specification

Qualifications

• Educated to at least degree level plus post graduate diploma OR evidence of equivalent specialist knowledge and experience
• Hold a Masters level qualification or possess equivalent demonstrable knowledge and experience to Masters level within this specialist field
• Demonstrates commitment to own continued professional development (CPD)

Experience

• Substantial experience and knowledge of Quality Systems and their application within a regulated environment, preferably relating to Substances of Human Origin
• Experience of building successful working relationships with internal and external colleagues
• Substantial experience in senior management, including providing effective leadership and team management.
• Experience and skills of report writing
• Experience of exercising autonomy within the work environment
• Advanced level experience of working with information technology using Microsoft Office packages (Outlook, Word, Excel, Teams and PowerPoint)

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.