Regional Regulatory Affairs Lead, US
Core
Build the US regulatory affairs function from the ground up, manage FDA relationships and submissions, and hold statutory roles for US market entry.
Role type
Senior regulatory affairs lead (medical devices)
Builds
US regulatory function, FDA submission pathways, and state-by-state expansion processes
Domain
Medical devices / Healthtech
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
FDA regulatory strategy, 510(k)/De Novo/PMA clearance leadership, pre-submission meeting management, US Agent/Importer/Distributor statutory roles, QMS setup, team building in greenfield settings, clinical expansion support, AI for regulatory intelligence
Preferred skills
SaMD experience, medtech engineering partnership, regional team scaling
Technologies
AI tools for regulatory intelligence and workflow automation
Responsibilities
Establish core RA processes, SOPs, and quality management system; manage FDA submissions and regulatory pathway implementation; lead state-by-state expansion planning; hold US Agent, Initial Importer, and Medical Device Distributor roles; shape global and US regulatory strategy
Seniority
Senior, hands-on IC with strategic ownership
