Senior Regulatory Affairs Specialist - Pleasanton, CA

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 experienced Senior Regulatory Affairs Specialist to support our growing Regulatory Affairs organization. This is a high-impact individual contributor role for a regulatory professional who can independently manage core regulatory activities, own moderately complex U.S. and international submissions, and provide strong cross-functional support across product development and sustaining activities. The ideal candidate brings solid FDA experience, working knowledge of global regulatory landscapes, and a proactive, collaborative mindset to navigating evolving regulatory requirements. As a member of the Calyxo Regulatory Team, you will work closely with Research & Development, Operations, Quality, Clinical and Medical Affairs, Marketing, and Legal to ensure regulatory alignment from concept through commercialization—balancing speed with compliance as we bring category-defining medical devices to market.  In This Role, You Will:  Prepare, author, and manage U.S. and international regulatory filings (including 510(k)s, letters to file, registrations/listings, and other regulatory submissions) with appropriate guidance for higher-risk or more complex issues, ensuring timely, high-quality deliverables.  Support the development and continuous improvement of regulatory processes, systems, templates, and documentation practices to help scale the Regulatory Affairs function as the company grows.  Serve as a key Regulatory Affairs representative on cross-functional teams and support communications with FDA and global regulatory bodies, including preparation for audits, inspections, and routine agency interactions.  Provide regulatory input into product development and design enhancements—including biocompatibility, sterilization, packaging, shelf life, clinical strategy, product changes, and labeling decisions—to help ensure compliance is built into the development process. Support Operations and cost-reduction projects as assigned.  Conduct regulatory review of promotional materials, advertising claims, and customer-facing communications in partnership with Regulatory Affairs leadership, ensuring consistency with approved claims and regulatory requirements.  Partner with Quality to support a QMS that meets global regulatory expectations and supports continuous improvement. S...