Job Description
We’re Hiring: Clinical Affairs Associate
Location: Woodland House, North Duffield, Selby, North Yorkshire
Company: GBUK Group | Medical Devices
Contract: Full-time | Hybrid
The role:
Are you looking for an opportunity to join a thriving, successful business whose continued growth and passion for enhancing patient care, means you can truly make a difference?
GBUK Ltd is a leading UK manufacturer and distributor of high‑quality medical devices, supporting patient care from admission through to rehabilitation. As a top‑20 supplier to the NHS and a provider of over 600,000 devices used daily worldwide, we deliver trusted solutions across enteral feeding, vascular access, patient handling, and critical care.
Headquartered in Selby, North Yorkshire, GBUK comprises specialist brands including GBUK Enteral, GBUK Healthcare, GBUK Banana Healthcare, and GBUK Vascular, we are known for innovative, safe, and clinically driven products. Our teams work closely with healthcare professionals to improve patient outcomes and uphold our core values of Integrity, Innovation, Adaptability, Collaboration and being Solution Focused.
In this Clinical Affairs role, you will play a crucial role in the business, at a key time of growth, being responsible for clinical documentation for inclusion within technical dossiers, post-market surveillance and post-market clinical follow-up planning, activities, monitoring, and reporting.
Key Responsibilities include:
* Evaluate clinical evidence from sources such as clinical investigations, literature, post-market surveillance activities, risk, and post market clinical follow up activities
* Preparing clinical evaluation plans and reports
* Preparing post market documentation such as post market surveillance plans, and periodic safety update reports
* Preparing post market clinical follow up documentation including clinical follow up plans and post market clinical follow up evaluation reports
* Updates to post market surveillance surveys and maintenance, tracking and reporting of results as well as market research to achieve market registration of devices
* Preparing SSCPs
* Working on clinical projects and processes, including clinical study management and follow up activities
* Ensuring compliance with regulations and guidance related to the given clinical document, as well as to GBUK SOPs
* Support with documentation reviews, providing clinical input, such as risk management files
* Assist in the preparation of annual QMS audits
* Provide clinical input, reviews and guidance to ensure compliance of device labelling, IFUs, marketing material and patient information leaflets
* Provide clinical and post market input to support New Product Development projects, for product launch, technical dossier compilation and device market approvals.
What will you be able to bring to the team?
Our ideal candidate would have a degree or equivalent certification in science related, medical, or engineering discipline alongside some experience of working within the Medical Device sector. Your written communication skills will be excellent and your attention to detail would be genuinely superb.
Above all, and most importantly, you will be a wonderful team player who cares about the work they do and will strive to provide top quality work, on time and work with the team around you to achieve excellence. You’ll be hungry to learn and keen to continuously develop and improve processes.
Any working knowledge of the MDR, MDD, UK MDR, IVDD, IVDR and related ISO standards would be helpful, as would knowledge of risk management implementation per ISO 14971.However, if in doubt, please reach out to us for a conversation and we can guide you further.
We look forward to welcoming applications from motivated professionals who share our commitment to exceptional patient care. If this sounds like you, we’d love to hear from you.
Why Join GBUK Group?
You will be part of a growing, purpose-led organisation where your work directly impacts patient care and device safety. The role offers plenty of opportunities for professional development, cross-functional collaboration, and meaningful contribution to the future of GBUK’s medical device portfolio.
Equality:
We are committed to creating an inclusive and diverse workplace and welcome applications from people of all backgrounds. We value the unique perspectives that individuals from different communities bring to our organisation. We encourage applications from candidates regardless of age, disability, gender identity or expression, marital or civil partnership status, pregnancy or maternity, race, religion or belief, sex, or sexual orientation.
We are happy to discuss reasonable adjustments to support you throughout the recruitment process and in the workplace.