Staff Regulatory Affairs Specialist - Pleasanton, CA

Job description

Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment. Kidney stone disease is a common, painful condition that consumes vast amounts of healthcare resources each year. Our team is led by executives and investors with a proven track record of commercializing paradigm-shifting devices to meet unmet needs within urology. Are you ready to change the future of kidney stone treatment? We are seeking high achievers who want to be part of a dynamic team working in a fun, diverse atmosphere. Summary: We are seeking an accomplished Staff Regulatory Affairs Specialist to serve as a senior individual contributor and subject matter expert within our growing Regulatory Affairs organization. This is a strategic, high-visibility role for a seasoned regulatory professional who can independently drive complex U.S. and international submissions, shape regulatory strategy across the product portfolio, and mentor junior team members. The ideal candidate brings deep FDA expertise, advanced command of global regulatory landscapes, and a proactive, collaborative mindset to nav...