Senior Regulatory Leader, SaMD & Digital Health

Intuitive; Sunnyvale (CA); On-site; USD 159,000 - 187,000; Full time

Job summary

Intuitive in Sunnyvale, CA, is seeking a Sr. Manager, Regulatory Affairs for the Digital Portfolio.

You will lead regulatory strategy and execution for software-driven products (SaMD/SiMD), cloud and AI-enabled features, and oversee a team of regulatory professionals across global markets. You will advise leaders on regulatory risk, manage 510(k)/premarket submissions, and ensure cybersecurity and lifecycle compliance in collaboration with Product Security, Legal, and Privacy.

Qualifications

• Bachelor's degree in engineering, life sciences, computer science, or 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.

Responsibilities

• Develop and execute global regulatory strategies for digital products.
• Advise cross-functional leaders on regulatory risk, timelines, and trade-offs.
• Lead preparation, review, and submission of 510(k), De Novo, and other premarket submissions.
• Lead interactions with FDA including pre-submission meetings and responses to deficiency requests.
• Guide regulatory strategy for AI/ML-enabled functionality, including model validation and lifecycle monitoring.
• Support postmarket activities including regulatory reporting for software issues.

Skills

Regulatory strategy

Leadership

Cross-functional collaboration

Regulatory submissions

FDA communications

Education

Bachelor's degree in engineering or life sciences

Job description

Intuitive in Sunnyvale, CA, is seeking a Sr. Manager, Regulatory Affairs for the Digital Portfolio.

You will lead regulatory strategy and execution for software-driven products (SaMD/SiMD), cloud and AI-enabled features, and oversee a team of regulatory professionals across global markets. You will advise leaders on regulatory risk, manage 510(k)/premarket submissions, and ensure cybersecurity and lifecycle compliance in collaboration with Product Security, Legal, and Privacy.