Senior Manager, Regulatory Affairs

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, 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.

Maintain regulatory intelligence on digital health, SaMD, AI, and cybersecurity regulations; assess impact and drive proactive readiness.

People Leadership

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.

Manage department priorities, resourcing, and budget for the digital portfolio.

Qualifications

Qualifications

Required

Bachelor's degree in engineering, life sciences, computer science, or a related technical field.

8+ years of regulatory affairs experience in medical devices, including 3+ years of direct experience with software, SaMD, or digital health products.

Demonstrated success leading US premarket submissions for software-containing devices.

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.

Preferred

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 US and EU, and direct health authority engagement.

Core Competencies

Strategic thinking: Translates evolving regulation into practical, business-aligned strategy.

Technical fluency: Engages credibly with software engineers, data scientists, and security experts.

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