Senior Manager, Regulatory Affairs

Intuitive Surgical seeks a Senior Manager of Regulatory Affairs to lead regulatory strategy and execution for software-driven medical products, including SaMD, cloud applications, and AI/ML-enabled features. This leader will manage a regulatory team, drive global compliance, and serve as the senior regulatory voice across cross-functional partners in a fast-moving digital health environment.

Responsibilities

• Develop and execute global regulatory strategies aligned with business priorities and product roadmaps
• Determine device classification, qualification, and submission pathways for software functions and features
• Lead preparation and submission of 510(k), De Novo, and premarket submissions to FDA
• Guide regulatory strategy for AI/ML functionality including model validation, bias assessment, and lifecycle monitoring
• Build and manage a high-performing regulatory team with scalable processes and tools

Requirements

• Bachelor's degree in engineering, life sciences, computer science, or related technical field
• 8+ years regulatory affairs experience in medical devices with 3+ years in software/SaMD/digital health
• Demonstrated success leading US premarket submissions for software-containing devices
• Working knowledge of FDA regulations (21 CFR 820, Part 11), EU MDR, software lifecycle, and cybersecurity
• 3+ years experience leading or managing people and cross-functional project teams
• Strong written and verbal communication with ability to influence senior stakeholders and regulators