Mgr, cQA RA
Core
Lead Quality and Regulatory Affairs strategy and operations for the UK, Ireland, and Malta region, ensuring compliance and supporting product portfolio lifecycle.
Role type
Senior IC Country Quality Assurance & Regulatory Affairs Manager
Builds
Regulatory strategies, Quality Management Systems (QMS), and compliant product launches/lifecycle management for pharmaceuticals and medical devices.
Domain
Healthcare, Pharmaceuticals, Medical Devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory strategy, QMS implementation, stakeholder management, risk mitigation, audit support, team leadership, project management
Preferred skills
Managing both pharmaceutical and medical device portfolios, CRO environment experience
Technologies
EU GDP, EU GMP, ISO 9001, ISO 13485, MDR
Responsibilities
Develop and execute regulatory strategies for new product launches and lifecycle management; Lead implementation and maintenance of the local Quality Management System; Manage and develop the UK, Ireland, and Malta CQA & RA team; Support internal and external inspections and audits; Coordinate field actions including recalls and safety notices.
Seniority
Senior, hands-on IC with leadership responsibilities
