Join the innovative team at Johnson & Johnson as a Senior Regulatory Affairs Specialist supporting the Monarch robotic surgery platform in Santa Clara, California. In this critical role, you will serve as the regulatory expert for our advanced medical technology solutions that are transforming minimally invasive surgical procedures across the globe. You will lead the development and execution of regulatory strategies while ensuring full compliance with FDA regulations and international standards throughout the product lifecycle. Key responsibilities include preparing and submitting regulatory applications including 510(k) submissions, PMA supplements, and CE mark dossiers for medical devices. You will collaborate closely with cross-functional teams including R&D, quality assurance, clinical affairs, and manufacturing to gather necessary documentation and ensure regulatory requirements are integrated from concept through commercialization. The role involves conducting regulatory impact assessments for product changes, managing regulatory databases, and maintaining current knowledge of evolving global regulations affecting surgical robotics and medtech devices. This position requires a bachelor's degree in a scientific or engineering discipline with a minimum of five years of regulatory affairs experience in the medical device industry. Advanced knowledge of FDA regulations, EU MDR, and ISO 13485 standards is essential. Candidates should demonstrate proven experience with medical device submissions and regulatory strategy development. Strong analytical, communication, and project management skills are required for success in this collaborative environment. Johnson & Johnson is the world's largest and most broadly based healthcare company, committed to using our reach and size for good. Our medtech surgery division develops innovative technologies that improve patient outcomes and advance the standard of care. We offer a comprehensive benefits package including competitive salary, health insurance, retirement savings plans, and wellness programs. Employees enjoy flexible work arrangements, professional development opportunities, and access to world-class training programs. Career growth opportunities include advancement into regulatory leadership roles, specialized therapeutic area expertise, or cross-functional positions within our global organization. The company supports continuing education and certification programs, providing a clear pathway for professional development in the rapidly evolving medtech regulatory landscape.