Senior Regulatory Affairs Lead, Digital Health & SaMD

Intuitive Surgical, Inc.; Sunnyvale (CA); Vor Ort; USD 187.000 - 280.000; Vollzeit

Zusammenfassung

Intuitive Surgical, Inc. in Sunnyvale, CA, is seeking a Sr. Manager, Regulatory Affairs for the Digital Portfolio to lead regulatory strategy and execution for SaMD/SiMD, cloud and AI-enabled features that support surgical care.

You will build and guide a regulatory team across Digital, R&D, Quality, Cybersecurity, Privacy, Legal, and Commercial partners. The role centers on 510(k) and De Novo submissions, PCCPs, and lifecycle compliance.

Qualifikationen

• Bachelor's degree in engineering, life sciences, computer science or related field.
• 8+ years in regulatory affairs for medical devices, including 3+ years with software/digital health.
• Experience leading US premarket submissions for software-containing devices.
• Knowledge of FDA regulations (21 CFR 820 / QMSR, 21 CFR Part 11) and EU MDR.

Aufgaben

• Develop and execute global regulatory strategies for digital products.
• Lead preparation and submission of 510(k), De Novo, and other PM submissions.
• Guide regulatory strategy for AI/ML, cybersecurity, and cloud platforms.
• Oversee lifecycle changes, labeling, and postmarket activities.
• Lead and develop a high-performing regulatory team.

Kenntnisse

Regulatory strategy

Leadership

Cross-functional collaboration

FDA regulations

Software regulatory

Communication

Risk assessment

Ausbildung

Bachelor's degree in engineering, life sciences, computer science

Master's degree preferred

Jobbeschreibung

Intuitive Surgical, Inc. in Sunnyvale, CA, is seeking a Sr. Manager, Regulatory Affairs for the Digital Portfolio to lead regulatory strategy and execution for SaMD/SiMD, cloud and AI-enabled features that support surgical care.

You will build and guide a regulatory team across Digital, R&D, Quality, Cybersecurity, Privacy, Legal, and Commercial partners. The role centers on 510(k) and De Novo submissions, PCCPs, and lifecycle compliance.