Regulatory Affairs Lead, SaMD & AI-Enabled Health Tech

Intuitive; California; Presencial; USD 180.000 - 240.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Travel up to 20%

Market-competitive compensation

Descripción de la vacante

Intuitive, a global leader in robotic-assisted surgery, is seeking a Sr. Manager, Regulatory Affairs for the Digital Portfolio in Sunnyvale, CA.

You will define and execute regulatory strategy for SaMD, SiMD, cloud, and AI/ML features, building a team and partnering with cross-functional stakeholders to bring innovative digital health products to market. In this role, you will own submissions, advise on risk, oversee lifecycle compliance, and collaborate with Product Security, Privacy, and Legal

Formación

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

Responsabilidades

• Develop and execute global regulatory strategies for digital products, aligned with business priorities and product roadmaps.
• Advise cross-functional leaders on regulatory risk, timelines, and trade-offs early in the design process.
• Lead preparation, review, and submission of 510(k), De Novo, and other premarket submissions.
• Own regulatory strategy for software change management, including determining when changes require new submissions and PCCPs where appropriate.
• Lead interactions with FDA including pre-submission meetings and responses to deficiency requests.
• Apply FDA software guidance and standards to digital product development and documentation.
• Guide regulatory strategy for AI/ML-enabled functionality, including model transparency, validation, data management, bias assessment, lifecycle monitoring, and change control.

Conocimientos

Regulatory strategy

FDA submissions

SaMD / software in medical devices

Cross-functional leadership

Educación

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

Descripción del empleo

Intuitive, a global leader in robotic-assisted surgery, is seeking a Sr. Manager, Regulatory Affairs for the Digital Portfolio in Sunnyvale, CA.

You will define and execute regulatory strategy for SaMD, SiMD, cloud, and AI/ML features, building a team and partnering with cross-functional stakeholders to bring innovative digital health products to market. In this role, you will own submissions, advise on risk, oversee lifecycle compliance, and collaborate with Product Security, Privacy, and Legal