Senior Manager, Regulatory Affairs

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.