Global Regulatory Strategy Lead — Medical Devices

Balt USA in Irvine, CA is seeking a Senior Principal Regulatory Affairs Specialist to lead regulatory approvals for high-risk medical devices, oversee submissions in the US and internationally, and guide cross-functional teams. You will develop global regulatory strategies, interact with regulatory agencies, and mentor teams while maintaining compliance and timelines. Requires nine+ years of regulatory experience, proven PMA/IDE/HDE experience, and strong writing and communication skills.