Regional Regulatory Affairs Lead, EMEA
Core
Build the EMEA Regulatory Affairs function from the ground up, manage relationships with MHRA and other authorities, and hold the UK Responsible Person role.
Role type
Senior Regulatory Affairs Lead (Greenfield/Build)
Builds
EMEA regulatory function, quality management systems, and scalable country-by-country expansion processes.
Domain
Medical Devices / HealthTech / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical device regulatory affairs, EU MDR CE marking, UK MHRA engagement, statutory UK Responsible Person, process/SOP development, greenfield team building, AI for regulatory intelligence
Preferred skills
Software as a Medical Device (SaMD), product development partnership, regional team scaling
Technologies
AI tools for regulatory intelligence and workflow automation
Responsibilities
Set up core RA processes and quality management systems; manage MHRA relationships and hold UKRP role; lead pre-submission and submission meetings; align UK, EU, and other jurisdictions; shape global and EMEA regulatory strategy.
Seniority
Senior, hands-on IC with strategic ownership
