Senior Manager, Regulatory Affairs

Company Description It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do  a global leader in robotic-assisted surgery and minimally invasive care, our technologies—like the da Vinci surgical system and Ion—have transformed how care is delivered for millions of patients worldwide.

We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.

The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement we make has the potential to change a life.

If you’re ready to contribute to something bigger than yourself and help transform the future of healthcare, you’ll find your purpose here.

Job Description Position Summary The Sr. Manager, Regulatory Affairs for the Digital Portfolio leads regulatory strategy and execution for software-driven products, including software as a medical device (SaMD), software in a medical device (SiMD), cloud and connected applications, data and analytics tools, and AI/ML-enabled features that support surgical care. This leader builds and manages a team of regulatory professionals and serves as the senior regulatory voice to Digital, R&D, Quality, Clinical, Cybersecurity, Privacy, Legal, and Commercial partners.

The role ensures that digital innovations reach customers quickly, compliantly, and sustainably across global markets.

Key Responsibilities Regulatory Strategy and Leadership Develop and execute global regulatory strategies for digital products, aligned with business priorities and product roadmaps.

Determine device classification, qualification, and pathway for software functions, including whether features meet the definition of a medical device or fall under enforcement discretion.

Advise cross-functional leaders on regulatory risk, timelines, and trade-offs early in the design process.

Represent Regulatory Affairs on digital product core teams and governance forums.

Manage the regulatory assessment and ongoing oversight of the non-medical device portfolio of products, including determining non-device status, maintaining supporting rationale and documentation, and ensuring claims, labeling, and software updates do not change a product's regulatory status.

Submissions and Market Authorization 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.

Software, AI/ML, and Cybersecurity Expertise Apply FDA software guidance and consensus standards (e.g., IEC 62304, IEC 82304-1, IEC 62366-1, ISO 14971, IEC 81001-5-1) 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; monitor evolving requirements such as the EU AI Act.

Ensure premarket cybersecurity expectations are met (e.g., FD&C Act Section 524B, SBOM, threat modeling, vulnerability management, postmarket plans) in partnership with Product Security.

Partner with Privacy and Legal on the interplay between medical device regulation and data protection requirements (e.g., HIPAA, GDPR).Lifecycle and Compliance Review and approve design changes,…