Senior Quality

3 days ago

North Yorks, United Kingdom GBUK Full time

Job DescriptionWe’re Hiring: Senior Quality & Regulatory Associate | GBUK Group (Bicester)Location: Telford Business Centre, Telford Rd, Bicester OX26 4LDReports to: Compliance DirectorGBUK 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.About the RoleThis 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 ResponsibilitiesDevelop and implement processes compliant with relevant standards and regulationsCreate and maintain technical documentation for manufactured medical devicesManage external product listings and support regulatory submissionsCollaborate with R&D and Design teams on product updates and new product introductionsPlan, conduct, and support internal and external supplier auditsLog, investigate, and document non-conformities and drive corrective actions (CAPA, NC)Prepare and present goods-in metrics and quality data for management reviewsConduct supplier evaluations and support supplier compliance meetingsWork with the Quality Control team to ensure timely and compliant product releaseSupport compliance assessments and undertake additional tasks as required by Quality, Regulatory, or Compliance leadershipEssential Experience and SkillsExperience in a Quality and/or Regulatory role within the Medical Device industryKnowledge of ISO 13485 or ISO 9001Experience in internal auditingStrong understanding of CAPA and Root Cause AnalysisAbility to write compliant processes and controlled documentsKnowledge of MDR requirementsStrong communication skills, attention to detail, and the ability to work collaborativelyProactive, organised, and able to manage multiple tasks and deadlinesDesirable ExperienceExperience reporting incidents to the MHRAExposure to external audits or notified body interactionsWhy 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 opportunities for professional development, cross-functional collaboration, and meaningful contribution to the future of GBUK’s medical device portfolio.

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