Wolters Kluwer · 1 month ago
Lead SaMD Technical Program Manager
USA - New York City, NY
Full-time
Hybrid
Senior Level, Lead/Staff
$146K/yr - $204K/yr
9+ years expWolters Kluwer is a company focused on delivering innovative solutions in the healthcare sector, and they are seeking a Lead SaMD Technical Program Manager. This role is responsible for driving the development and delivery of Software as a Medical Device (SaMD) products while ensuring compliance with global regulatory standards and facilitating cross-functional collaboration.
BankingFinanceInformation ServicesInformation TechnologyLegalMobilePublishingSoftware
Responsibilities
Lead SaMD Development Projects: Drive the functional planning, execution, and delivery of SaMD projects, ensuring effective delivery and alignment with relevant regulatory standards and organization SOPs
Project Management: Apply best-practice project management methodologies to ensure adherence to project timelines, requirements, and goals. Create and maintain dashboards, project plans, schedules, charters, and risk registers to monitor progress and performance, resolve operational issues, and minimize any potential delays. Execute multiple projects simultaneously, prioritizing competing initiatives. Organize and lead project team meetings with detailed agendas, documenting key tasks, action items, and decisions
Lifecycle Management: Lead SaMD product development initiatives from Project Kickoff to End-of-Life, ensuring all required lifecycle management activities are planned and executed, including new product development, change management, post-market surveillance, and maintenance activities
Risk Management: Lead Project risk mitigation activities, including timeline, resource, and budgetary risks that arise during the device lifecycle to ensure business priorities are met. Support device and compliance risk management activities (hazard analysis, risk assessments) throughout the device life cycle
Cross-Functional Collaboration: Act as a liaison between engineering, product, regulatory affairs, clinical, and QA teams to resolve dependencies, facilitate strategic decision-making, and drive process improvement. Coordinate meetings and project deliverables
Metrics and Reporting: Track and communicate key metrics (risk status, milestone progress, documentation completeness, team velocity) to technical and business stakeholders
Stakeholder Engagement: Engage with executive stakeholders to ensure product needs are understood, prioritized, and delivered
Process Improvement: Research, recommend, and implement new practices and automation opportunities to accelerate delivery and improve compliance
Qualification
Required
Bachelor's degree in engineering, computer science, or related field (or equivalent practical experience)
9+ years of experience working on SaMD or regulated medical software products in technical program management, engineering, or project management roles using agile practices. Knowledge of FDA and EU MDR-related standards
Hands-on experience with design control, risk management, and technical documentation (DHF, traceability matrix, protocols, reports, risk assessments, testing, etc.)
Demonstrated experience working under a formal QMS (ISO 13485, 21 CFR 820)
Experience working with an eQMS and other tooling for managing SaMD projects
Strong understanding of modern agile software development practices and adaptive program management
Excellent communication, leadership, and organizational skills; ability to work effectively in a matrixed, cross-functional environment
Experience supporting products through the full lifecycle, including post-market activities
Ability to analyze data and communicate effectively through written and graphical formats to large audiences, including executives
Preferred
Experience with cybersecurity and/or AI/ML compliance for medical software is a plus
Agile, PMP and Regulatory Certifications are a plus
Company
Wolters Kluwer
Wolters Kluwer is an information services company specializing in software solutions and services for the healthcare and legal sectors.
10001+ employees
H1B Sponsorship
Wolters Kluwer has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (94)
2024 (22)
2023 (23)
2022 (10)
2021 (3)
Funding
Current Stage
Public CompanyTotal Funding
$1.78B2025-06-23Post Ipo Debt· $578.76M
2025-03-13Post Ipo Debt· $542.74M
2024-03-11Post Ipo Debt· $655.84M
Leadership Team
Jason Marx
CEO, Wolters Kluwer Tax & Accounting
Nancy McKinstry
CEO
Recent News
2026-01-11
2026-01-07
Company data provided by crunchbase