Senior Specialist, International Regulatory Affairs TMTT
Core
Develop and execute regulatory strategies for Transcatheter Mitral and Tricuspid Therapies (TMTT) devices, preparing complex domestic and international submissions to ensure product approval and market access.
Role type
Senior Specialist, International Regulatory Affairs
Builds
Regulatory submissions and strategies for TMTT medical devices
Domain
Medical Devices / Cardiovascular Therapies
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory submission preparation, global regulatory strategy, stakeholder alignment, timeline management, conflict resolution between development and regulatory requirements, process improvement
Preferred skills
Scientific degree background, Class II/III device regulation knowledge, new product development systems knowledge, international regulatory requirements expertise, analytical problem-solving
Technologies
Regulatory submission platforms, global regulatory databases
Responsibilities
Create complex regulatory submissions for OUS EW affiliates, represent regulatory function on manufacturing and product development teams, provide guidance on strategies and contingency planning for global regulations, offer feedback to business unit teams on registration requirements and labeling content
Seniority
Senior, hands-on IC