Clinical Affairs Associate

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. Based in Selby, North Yorkshire, GBUK comprises specialist brands including GBUK Enteral, GBUK Healthcare, GBUK Banana Healthcare, and GBUK Vascular, 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.

We are looking for someone to join our Regulatory team to enhance the Team at our Selby site. A full driving licence and own car is essential as there are no public transport links to our site.

About the Role

This key role is 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

• Evaluate clinical evidence from sources such as clinical investigations, literature, post-market surveillance activities, risk, and post market clinical follow up activities.
• Analyse the results for inclusion / exclusion within clinical evaluations.
• Preparing clinical evaluation plans and reports.
• Preparing post market documentation i.e., post market surveillance plans and reports, periodic safety update reports.
• Preparing post market clinical follow up documentation i.e., post market clinical follow up plans and post market clinical follow up evaluation reports.
• Updates to post market surveillance surveys; Maintenance, tracking and reporting of post market surveillance survey results.
• Aid in market research to achieve market registration of devices.
• Preparing SSCPs.
• Working on clinical projects and processes, including clinical study management and post market clinical follow up activities.
• Ensuring compliance with all applicable regulations and guidance related to the given clinical document, and adhering to GBUK SOPs.
• Support with internal and external department documentation reviews and provide clinical input, such as risk management files.
• Assist in the preparation for annual QMS audits, supporting in regular internal and external audits.
• Provide clinical input, reviews and guidance to ensure compliance of device labelling, IFUs, marketing material, patient information leaflets.
• Provide clinical and post market input and guidance to support New Product Development Projects, for product launch, technical dossier compilation, and device market approvals.

Essential Experience and Skills

• Degree or equivalent certification in science related, medical, or engineering discipline.
• Experience of working within a Medical Device sector (ideally 3 or more years’ experience).
• Experience of clinical and/or medical writing.
• Working knowledge of the MDR, MDD, UK MDR, IVDD, IVDR and related ISO standards.
• Management and maintenance of various databases and tracking tools such as excel.
• Have the ability to assess all necessary and specific clinical obligations as appropriate for the device, to ensure regulatory compliance.

Desirable

• Experience of market submissions and approval.
• Experience of conducting clinical studies or post market surveillance and post market clinical follow up activities.
• Experience of assisting with/conducting/managing Internal & External audits.
• Knowledge and/or Experience of technical dossiers and the clinical documents required for such.
• Experience with Clinical Evaluation compilation to current MEDDEV and MDCG guidance, and Risk Management implementation per ISO 14971.
• Project Management experience.

Additional Requirements

• Capable problem solver, able to work in a team and independently.
• Competent in clinical / medical writing and extracting and interpreting clinical data and literature.
• Able to project manage multiple tasks.
• Excellent communication skills.
• Organised working style with excellent eye for detail.
• High level of computer literacy.

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.

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.