Senior Manager, Regulatory Affairs
About The Position
The Senior Manager, Regulatory Affairs for the Digital Portfolio leads regulatory strategy and execution for software-driven products, including SaMD, SiMD, cloud and connected applications, data and analytics tools, and AI/ML-enabled features supporting surgical care. The role builds and manages a regulatory team and serves as the senior regulatory voice to Digital, R&D, Quality, Clinical, Cybersecurity, Privacy, Legal, and Commercial partners. It ensures digital innovations reach customers quickly, compliantly, and sustainably across global markets. The position develops global regulatory strategies aligned with business priorities and product roadmaps; determines software classification, qualification, and regulatory pathways; and advises cross-functional leaders on regulatory risk and trade-offs. It leads premarket submissions and FDA interactions, oversees software change management, and guides regulatory approaches for AI/ML, cybersecurity, privacy, and data protection. The role also supports lifecycle compliance, postmarket activities, inspections, audits, regulatory intelligence, and quality system procedures. As a people leader, it recruits, develops, and retains team members, builds scalable processes and tools, and manages priorities, resourcing, and budget for the digital portfolio. The position is based in Sunnyvale, California, with a set schedule and weekly onsite work; the percentage of onsite work is defined by the leader. Travel may be up to 20% for health authority meetings, site visits, and conferences.
Requirements
- Bachelor's degree in engineering, life sciences, computer science, or a related technical field.
- At least 8 years of regulatory affairs experience in medical devices, including at least 3 years of direct experience with software, SaMD, or digital health products.
- Demonstrated success leading U.S. premarket submissions for software-containing devices.
- Working knowledge of FDA regulations (21 CFR 820/QMSR and 21 CFR Part 11), EU MDR, and software lifecycle and cybersecurity requirements.
- At least 3 years of experience leading or managing people or cross-functional project teams.
- Strong written and verbal communication skills, with a proven ability to influence senior stakeholders and regulators.
Nice To Haves
- Master's degree or advanced degree in a relevant field.
- Experience with AI/ML-enabled medical devices, PCCPs, and cloud-based or connected platforms.
- Experience with robotic-assisted surgery, surgical data, or enterprise-scale digital ecosystems.
- Regulatory Affairs Certification (RAC) or equivalent.
- Experience with global markets beyond the U.S. and EU, and direct health authority engagement.
Responsibilities
- Develop and execute global regulatory strategies for digital products aligned with business priorities and product roadmaps.
- Determine device classification, qualification, and pathways for software functions, including whether features meet the definition of a medical device or fall under enforcement discretion.
- Advise cross-functional leaders on regulatory risks, timelines, and trade-offs early in the design process.
- Represent Regulatory Affairs on digital product core teams and governance forums.
- Manage regulatory assessment and ongoing oversight of non-medical-device products, including determining non-device status, maintaining supporting rationale and documentation, and ensuring claims, labeling, and software updates do not alter regulatory status.
- 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 using Predetermined Change Control Plans (PCCPs) where appropriate.
- Lead FDA interactions, including pre-submission meetings and responses to deficiency requests.
- Apply FDA software guidance and consensus standards to digital product development and documentation.
- Guide regulatory strategy for AI/ML functionality, including model transparency, validation, data management, bias assessment, lifecycle monitoring, and change control; monitor evolving requirements such as the EU AI Act.
- Partner with Product Security to ensure premarket cybersecurity expectations are met, including SBOM, threat modeling, vulnerability management, and postmarket plans.
- Partner with Privacy and Legal on the interplay between medical device regulation and data protection requirements such as HIPAA and GDPR.
- Review and approve design changes, labeling, instructions for use, and promotional or digital content for regulatory compliance.
- Support postmarket complaint and adverse event assessment, field actions, and regulatory reporting for software issues.
- Support FDA and MDSAP inspections and audits, and contribute to quality system procedures for software and digital development.
- Maintain regulatory intelligence on digital health, SaMD, AI, and cybersecurity regulations; assess impacts and drive proactive readiness.
- Recruit, develop, coach, and retain a high-performing team; set goals, allocate work, and foster an inclusive, collaborative culture.
- Build scalable processes, templates, and tools that improve submission quality and speed.
- Manage department priorities, resourcing, and budget for the digital portfolio.
Benefits
- Market-competitive compensation packages including base pay, incentives, benefits, and equity.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
