Regulatory Affairs Technical Lead
Core
Leads global regulatory strategy, submissions, and compliance for enterprise-wide medical device products and platforms.
Role type
Senior Regulatory Affairs Technical Lead
Builds
Global regulatory strategies, submissions, and compliance frameworks for complex medical device portfolios.
Domain
Medical Devices / Regulatory Affairs
Required skills
Global regulatory strategy, FDA clearance for ML/CADe/x, executive communication, leadership, technical writing, analytics, project management, agency relations
Preferred skills
None stated
Technologies
ML, CADe/x
Responsibilities
Develop global regulatory strategies, lead regulatory submissions and agency communications, respond to agency inquiries/inspections, mentor team members, provide executive metrics and dashboards, represent company in industry forums
Seniority
Senior, hands-on IC with executive-level advisory