Senior Quality

2 weeks ago

York and North Yorkshire, United Kingdom GBUK Full time

Senior Quality & Regulatory Associate Location: Tord Business Centre, Telford Rd, Bicester OX26 4LD Reports to: Compliance Director We’re Hiring: Senior Quality & Regulatory Associate | GBUK Group (Bicester) GBUK Group is a leading provider of specialist medical devices, trusted by healthcare professionals across the UK and internationally. We are expanding our team and seeking a Senior Quality & Regulatory Associate to support and enhance our Quality and Regulatory activities across our Bicester and Newbury sites. This range is provided by GBUK will be based on your skills and experience — talk with your recruiter to learn more. About the Role This key role is responsible for maintaining technical documentation, managing quality processes and supporting regulatory compliance. You will work closely with R&D, Design, and Compliance teams to ensure our products meet regulatory requirements and high-quality standards. Key Responsibilities Develop and implement processes compliant with relevant standards and regulations Create and maintain technical documentation for manufactured medical devices Manage external product listings and support regulatory submissions Collaborate with R&D and Design teams on product updates and new product introductions Plan, conduct, and support internal and external supplier audits Log, investigate, and document non‑conformities and drive corrective actions (CAPA, NC) Prepare and present goods‑in metrics and quality data for management reviews Conduct supplier evaluations and support supplier compliance meetings Work with the Quality Control team to ensure timely and compliant product release Support compliance assessments and undertake additional tasks as required by Quality, Regulatory, or Compliance leadership Essential Experience and Skills Experience in a Quality and/or Regulatory role within the Medical Device industry Knowledge of ISO 13485 or ISO 9001 Experience in internal auditing Strong understanding of CAPA and Root Cause Analysis Ability to write compliant processes and controlled documents Knowledge of MDR requirements Strong communication skills, attention to detail, and the ability to work collaboratively Proactive, organised, and able to manage multiple tasks and deadlines Experience reporting incidents to the MHRA Exposure to external audits or notified body interactions You will be part of a growing, purpose‑led organisation where your work directly impacts patient care and device safety. The role offers opportunities for professional development, cross‑functional collaboration, and meaningful contribution to the future of GBUK’s medical device portfolio. Seniority level Associate Employment type Full‑time Job function Quality Assurance Industries Medical Equipment Manufacturing #J-18808-Ljbffr

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