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.
About the Role
Reporting to the Compliance Director, this key role is responsible for maintaining technical documentation, managing quality processes, supporting regulatory compliance, and overseeing the Quality Control function. 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
* Coordinate the work of 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
* Experience of working to a recognised QMS: ISO 13485 or ISO 9001 as a minimum
* Experience in internal auditing
* Strong understanding of CAPA and Root Cause Analysis
* Ability to write compliant processes and controlled documents
Desirable Experience
* Knowledge or experience of MDR requirements
* Experience or knowledge of reporting incidents to the MHRA
* Exposure to external audits or notified body interactions
* Excellent interpersonal skills, including the ability to work as part of a team and to work with people from across the whole company.
* Good organisation and leadership skills with attention to detail. A can-do attitude with the ability to take initiative and work to deadlines across multiple simultaneous tasks and projects.
* Good written and verbal communication skills.
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 opportunities for professional development, cross-functional collaboration, and meaningful contribution to the future of GBUK’s medical device portfolio.
Equality
All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law.
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