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We are recruiting for a Quality Assurance & Regulatory Affairs Administrator to join a growing medical technology organisation supporting compliance and quality systems across its global product range. This is a great opportunity for someone with experience in regulated environments such as medical devices, life sciences or pharmaceuticals who enjoys working with quality documentation, regulatory processes and compliance systems.
Job Responsibility:
Maintain and update the Quality Management System (QMS) in line with ISO 13485
Manage document control processes, ensuring accurate revision and distribution of documents
Support CAPA, non-conformance, complaints and change control processes
Assist with internal and external quality audits
Maintain training records and compliance documentation
Support regulatory submissions and product registrations
Monitor regulatory updates and support ongoing compliance activities
Requirements:
Experience working in a regulated industry (medical devices, pharmaceutical, life sciences or similar)
Understanding of ISO 13485, EU MDR or FDA quality requirements
Strong organisational and administrative skills
Excellent attention to detail
Confident using Microsoft Office (Word, Excel, Outlook, Teams)
Nice to have:
Degree in Quality, Engineering, Life Sciences or similar