Regulatory Affairs jobs in United Kingdom

The CESS team's ever-expanding role supports the Trust in developing systems to achieve compliance with legal, regulatory, quality, professional and best practice standards relating to the safe acquisition, use and management of healthcare technologies. This post will also support the CESS manager's advisory role in the development of Trust strategies, policies and operational practices relating to medical devices.

This role will include leading on delegated projects e.g., rolling replacement programmes, clinical evaluations and writing specifications as specified by the medical device governance lead.

• Act as a point of contact for all enquiries involving medical devices and emerging healthcare technologies.
• Advise clinical staff on a broad range of healthcare technology, assessing devices available on the market and making judgements on suitability for the intended purpose, taking into account elements such as UK based maintenance support and ease of use etc. and balancing this against clinical preference.
• Manage medical devices procurement projects, including writing, specifications, monitoring expenditure of allocated capital funding, following tender and purchasing processes, planning clinical evaluations.
• Extrapolate and analyse information from Trust data systems to produce reports e.g., monitoring of device related clinical incidents supporting device replacement programmes, planned maintenance requirements and evidence for regulatory standards.
• Act as a visible, accessible, and assertive resource for medical device users; to be a credible authoritative source of expert advice to managerial, medical, clinical, and technical staff and patients on the safe use, maintenance and management of medical devices and a pro‑active champion of best practice in their clinical application throughout the Trust.
• Provide support to the Medical Device Training Co‑ordinator in the delivery of medical device training programmes.
• Act as mentor for Clinical Scientist trainees and participate in joint training programmes in collaboration with external education organisations.

For a more detailed job description, main responsibilities, and Person Specification, please refer to the job description document attached to this vacancy.

• Broad range of professional experience in the field of medical devices, their management, and their clinical application.
• Sound knowledge of relevant legislation, national standards, professional and other guidelines, procedures, and practices relating to safe and effective use of medical devices.

• Experience of investigating clinical incidents involving medical devices and participating in patient safety investigations, including awareness of ergonomic and user factors that impact on the safe use of medical devices.
• Knowledge and understanding of clinical governance and clinical risk management, including health and safety, infection control, manual handling, etc.

• Able to engage professionally and credibly at senior management level.
• Able to respond, prioritise and analyse complex problems/situations and ensure effective interventions are put in place.
• Able to communicate clearly and effectively through a range of different media (posters/work sheets/emails/etc.) and engage others.
• Advanced software use of Microsoft Office and other systems to extract, analyse, summarise, and report.
• Able to present and receive complex information to a multi‑professional audience.
• Able to deal effectively with interpersonal conflict through being assertive and having demonstrable negotiating and influencing skills.
• Ability to work autonomously within own specialist area, exercising initiative and leadership in delegated projects.

• Team player who can initiate, delegate and complete projects.

• Systems thinker able to consider the wider picture when assessing complex medical device clinical utilisation scenarios.
• Keen sense of innovation to help keep "Healthcare at the limits of science".
• Appreciation of the changing face of medical devices and increased move towards digital devices.

• Interest in training scheme development and leading training of other staff.
• Interest in medical device research.

• Good honours degree in a relevant engineering discipline.
• Masters level qualification in a relevant engineering discipline or equivalent experience.
• Work towards attaining or maintaining accreditation as a registered Clinical Scientist with the Health & Care Professions Council (HCPC).

• Management qualification (level 5) or equivalent experience.

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). UK Registration: Applicants must have current UK professional registration. For further information please see NHS Careers website (opens in a new window).

University Hospitals Bristol and Weston NHS Foundation Trust (UHBW)

St Michaels Hospital, Southwell Street, Bristol, BS2 8EG

Employer's website: https://www.uhbw.nhs.uk/ (Opens in a new tab)

Date posted: 19 December 2025

Pay scheme: Agenda for change

Band: Band 6

Salary: £38,682 to £54,710 a year (Linked progression depending on HCPC registration)

Contract: Permanent

Working pattern: Full‑time

Reference number: 387‑DT8854‑LMG

Job locations: St Michaels Hospital, Southwell Street, Bristol, BS2 8EG