Staff Regulatory Affairs Specialist - Pleasanton, CA Pleasanton, CA

Staff Regulatory Affairs Specialist - Pleasanton, CA Pleasanton, CA Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA that has focused on improving kidney stone treatment. The company was founded in 2016 and is led by executives with a proven track record of commercializing paradigm‑shifting devices. 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 high‑visibility role will independently drive complex U.S. and international submissions, shape regulatory strategy, and mentor junior team members. In This Role, You Will Lead the strategy, preparation, submission, and negotiation of complex U.S. and international regulatory filings (510(k)s, Q‑Submissions, Special 510(k)s, Letters to File). Drive development and continuous improvement of scalable regulatory infrastructure. Act as primary liaison with FDA and global regulatory bodies. Provide expert regulatory input into product development and design enhancements. Oversee regulatory review and approval of promotional materials and claims. Partner with Quality to ensure QMS meets global regulatory expectations. Monitor and interpret proposed regulatory changes and translate them into actionable guidance. Maintain visibility into evolving global regulatory requirements. Lead risk management and field action processes. Drive regulatory compliance activities such as CAPAs, NCMRs, and MDR/eMDR processes. Mentor and develop junior Regulatory Affairs staff. Champion a culture of regulatory excellence, knowledge sharing, and continuous improvement. Maintain current knowledge of the regulatory landscape and act as the in‑house subject matter expert. Who You Will Report To Director, Regulatory Affairs Requirements 12+ years of experience in regulatory affairs in the medical device, biotechnology, or in‑vitro diagnostics industry, with substantial experience with Class II or Class III electromechanical medical devices. Extensive prior experience interfacing with the FDA and other regulatory agencies. Proven success independently leading multiple FDA submissions. Recognized expertise in biocompatibility, packaging, sterilization, software (IEC 62304), electrical safety and EMC (IEC 60601), labeling, and product claims. Advanced understanding of U.S. regulatory requirements and working knowledge of EU MDR and other international regulations. Demonstrated ability to lead cross‑functional teams and strong technical writing skills. Strong analytical capabilities and experience with medical device eQMS. Proven mentor and coach. Effective communicator and relationship builder. Bachelor’s degree in Life Sciences, Engineering, or related field; advanced degree and/or RAC certification strongly preferred. Location: Pleasanton office (minimum 3 days a week onsite). Must be able to sit for up to 8 hours a day. Compliance with relevant county, state, and federal rules regarding vaccinations. What We Offer Competitive salary of $160,000–$175,000 and variable incentive plan. Stock options – ownership and a stake in a mission‑driven company. Employee benefits package including 401(k), healthcare insurance, and paid vacation. Calyxo is deeply committed to fostering an environment where diversity and inclusion are not only valued but also prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly. Calyxo is proud to be an equal‑opportunity employer; all applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, genetics, disability, age, veteran status, or any other legally protected characteristic. Legal authorization to work in the United States is required. At Calyxo, we verify identity and eligibility to work in the United States and require completion of the employment eligibility verification form upon hire. #J-18808-Ljbffr