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For Companies At a Glance
- Tasks: Join us in enhancing patient care through clinical documentation and innovative medical device projects.
- Company: GBUK Group, a leading UK manufacturer of high-quality medical devices.
- Benefits: Hybrid work, professional development, and a chance to make a real impact.
- Why this job: Be part of a purpose-led organisation that values your contributions to patient safety.
- Qualifications: Degree in science, medical, or engineering; experience in the Medical Device sector preferred.
- Other info: Inclusive workplace welcoming diverse backgrounds and perspectives.
The predicted salary is between 28800 - 48000 £ per year.
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 a 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.
Clinical Affairs Associate, Medical Devices in Selby employer: GBUK
Contact Detail:
GBUK Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Affairs Associate, Medical Devices in Selby
✨Tip Number 1
Network like a pro! Reach out to professionals in the medical device sector on LinkedIn or at industry events. A friendly chat can open doors that applications alone can't.
✨Tip Number 2
Prepare for interviews by researching GBUK Group and their products. Show us you’re genuinely interested in enhancing patient care and how your skills align with our mission.
✨Tip Number 3
Practice your responses to common interview questions, especially around clinical documentation and compliance. We want to see your expertise shine through!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take that extra step.
We think you need these skills to ace Clinical Affairs Associate, Medical Devices in Selby
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Clinical Affairs Associate role. Highlight your relevant experience in the medical device sector and showcase how your skills align with our core values of Integrity, Innovation, and Collaboration.
Show Off Your Writing Skills: Since excellent written communication is key for this role, take the time to proofread your application. Clear, concise, and error-free writing will demonstrate your attention to detail and professionalism.
Be Genuine and Passionate: Let your enthusiasm for enhancing patient care shine through in your application. We want to see that you genuinely care about the work you do and are eager to contribute to our mission at GBUK Group.
Apply Through Our Website: For the best chance of success, make sure to submit your application directly through our website. This way, we can easily track your application and ensure it reaches the right people in our team.
How to prepare for a job interview at GBUK
✨Know Your Stuff
Make sure you brush up on the latest regulations and standards in the medical device sector, especially the MDR and ISO 14971. Being able to discuss these confidently will show that you're serious about the role and understand the industry.
✨Showcase Your Team Spirit
GBUK values collaboration, so be ready to share examples of how you've worked effectively in a team. Highlight your ability to communicate and support your colleagues, as this is crucial for success in the Clinical Affairs role.
✨Prepare for Technical Questions
Expect questions about clinical documentation and evaluation plans. Familiarise yourself with the types of documents you'll be preparing, like post-market surveillance plans and clinical follow-up reports, so you can speak about them with ease.
✨Ask Insightful Questions
At the end of the interview, don’t shy away from asking questions. Inquire about GBUK's approach to innovation in patient care or how they support professional development. This shows your genuine interest in the company and the role.
