Senior Specialist, International Regulatory Affairs TMTT
Based in United States
Core
Create complex regulatory submissions for Transcatheter Mitral and Tricuspid Therapies (TMTT) products to guide innovative technologies through domestic and international regulatory environments.
Role type
Senior Specialist, International Regulatory Affairs
Builds
Regulatory submissions and strategies for TMTT medical devices
Domain
Medical Devices / Cardiovascular
Required skills
Regulatory submission preparation, Global regulatory strategy, Stakeholder management, Timeline tracking, Risk assessment, Process improvement
Preferred skills
Scientific degree background, Class II/III device regulations, New product development systems, International regulatory requirements, Problem-solving, Analytical thinking