Intuitive Autonomy
Senior Manager, Regulatory Affairs
Sunnyvale, CA, United States · Senior · Contract
Sponsorship not specifiedDetected 1 day ago
Machine LearningCybersecurityComplianceAccessibilityHIPAAFDA RegulatoryMedical DevicesLeadershipCommunicationCollaborationRegulatory Affairs
Stay score
odds of building a lasting career here
37Risky
Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
Thin sponsorship signal and lottery-bound. A low-probability bet with your clock running. Prioritize cap-exempt roles and proven entry-level sponsors first.
Lottery odds assume a STEM candidate.
Personalize to your clock →Community outcomes
No reports yet — be the first to help the next applicant.
About the role
- The role ensures that digital innovations reach customers quickly, compliantly, and sustainably across global markets.
Responsibilities
- 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 leveraging Predetermined Change Control Plans (PCCPs) where appropriate.
- Lead interactions with FDA including pre-submission meetings and responses to deficiency requests.
- Review and approve design changes, labeling, instructions for use, and promotional/digital content for regulatory compliance.
- Support postmarket activities including complaint and adverse event assessment, field actions, and regulatory reporting for software issues.
- Support inspections and audits (FDA, MDSAP) and contribute to quality system procedures for software and digital development.
- Recruit, develop, coach, and retain a high-performing team; set clear goals, allocate work, and foster an inclusive, collaborative culture.
- Build scalable processes, templates, and tools that improve submission quality and speed.
Requirements
- Bachelor's degree in engineering, life sciences, computer science, or a related technical field.
- 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.
- Master's degree or advanced degree in a relevant field.
- Experience with robotic-assisted surgery, surgical data, or enterprise-scale digital ecosystems.
Skills
- It started with a simple idea: what if surgery could be less invasive and recovery less painful?
Benefits
- If you're ready to contribute to something bigger than yourself and help transform the future of healthcare, you'll find your purpose here.
- Determine device classification, qualification, and pathway for software functions, including whether features meet the definition of a medical device or fall under enforcement discretion.
Company info
- If you require assistance or an accommodation during any part of the application or interview process, please contact People Services at HRHelpNow@intusurg.com.
Equal opportunity
- Intuitive is an Equal Opportunity Employer.
- Accommodation & Accessibility Notice:
Apply directly at Intuitive Autonomy →Create a free account for alerts like thisView Intuitive Autonomy immigration profile
This listing is sourced directly from Intuitive Autonomy's careers page and normalized into a canonical job model.