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Regulatory Affairs Manager
Katalyst Healthcares & Life Sciences
📍
Irvine, California, United States
Location
Irvine, California
Posted
May 08, 2026
Commute
Local Area
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This job is in your area. Enjoy a short commute and work close to home.
Job Description
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...