Katalyst HealthCares & Life Sciences | Raleigh, United States | Posted July 02, 2026
Position Overview
Responsibilities:
In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key markets such as USA (FDA), EU (MDR), China (NMPA), and more.
You will work cross-functionally with Clinical, Global Regulatory Affairs counterparts, and others to support innovation and expand market access for our advanced ultrasound technologies and solutions.
Develop and implement global regulatory strategies for new product registrations, software updates (including AI-powered features) and product lifecycle management.
Lead preparation and submission of technical documentation and regulatory dossiers to authorities such as NMPA, FDA, EU notified bodies, and other international regulatory agencies.
Oversee and coach a team of regulatory professionals to support both strategic...