Wolters Kluwer

Compensation

Full Description

The Principal SaMD Technical Program Manager plays a pivotal role in driving the development and delivery of Software as a Medical Device (SaMD) products. This position is responsible for enabling engineering teams to operate at high velocity while ensuring strict compliance with global regulatory standards such as FDA, EU MDR, ISO 13485, and IEC 62304. They are responsible for creating and managing the software development plan and partnering with engineering, quality, and regulatory team members to aligning the process with agile and lean engineering practices. This approach empowers teams to innovate rapidly while maintaining audit-ready outputs and supporting the full product lifecycle, including post-market surveillance and ongoing compliance maintenance. Collaboration and leadership are central to this role. The Principal SaMD TPM acts as a bridge between engineering, product, regulatory affairs, clinical, and quality assurance teams, facilitating strategic decision-making and resolving cross-functional dependencies. They provide oversight to various aspects of the project portfolio, coordinating meetings and project deliverable milestones. They are responsible for tracking and communicating key metrics—such as risk information, documentation completeness, and team velocity—to both technical and business stakeholders. By engaging with executive leadership and managing demand from diverse sources, they ensure that product needs are clearly understood, prioritized, and delivered in alignment with organizational goals. As a catalyst for continual improvement, the Principal SaMD TPM researches, recommends, and implements new practices and automation opportunities to accelerate delivery and align activities with key business objectives and product initiatives. The role requires hands-on expertise in agile software development, process facilitation (Scrum, Kanban), and adaptive program management. Through a combination of technical acumen, process optimization, and collaborative leadership, they drive the organization’s mission to deliver safe, effective, and innovative medical software solutions. 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. Qualifications: 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. Experience with cybersecurity and/or AI/ML compliance for medical software is a plus. Agile, PMP and Regulatory Certifications are a plus. Our Interview Practices To maintain a fair and genuine hiring process, we kindly ask that all candidates participate in interviews without the assistance of AI tools or external prompts. Our interview process is designed to assess your individual skills, experiences, and communication style. We value authenticity and want to ensure we’re getting to know you—not a digital assistant. To help maintain this integrity, we ask to remove virtual backgrounds and include in-person interviews in our hiring process. Please note that use of AI-generated responses or third-party support during interviews will be grounds for disqualification from the recruitment process. Applicants may be required to appear onsite at a Wolters Kluwer office as part of the recruitment process. Compensation: Target salary range CA, CT, CO, DC, HI, IL, MA, MD, MN, NY, RI, WA: $145,500 - $203,900 If making a difference matters to you, then you matter to us. Join us, at Wolters Kluwer, and be part of a dynamic global technology company that makes a difference every day. We’re innovators with impact. We provide expert software and information solutions that the world’s leading professionals rely on, in the moments that matter most. You’ll make a real difference in the lives of millions of people. Together with our customers, we help to advance sustainability, health, justice, prosperity, and commerce around the world. You can thrive at Wolters Kluwer, where diversity is core to our collective strength and high performance. Be your unique self, share your creative ideas, do your best work, and take time to grow in our caring and inclusive culture where you can belong. Wolters Kluwer reported 2023 annual revenues of €5.6 billion. The group serves customers in over 180 countries, maintains operations in over 40 countries, and employs approximately 21,400 people worldwide. Our customers work in industries which impact the lives of millions of people every single day. Our mission is to empower our professional customers with the information, software solutions, and services they need to make critical decisions, achieve successful outcomes, and save time. Our expert solutions combine deep domain knowledge with technology to deliver both content and workflow automation to drive improved outcomes and productivity for our customers. We are committed to helping professionals improve the way they do business and solve complex problems with our range of digital solutions and services, which we continuously evolve to meet their changing needs. Our 188-year legacy and portfolio represent thousands of customers worldwide. For more information about our solutions and organization, visit www.wolterskluwer.com, follow us on Twitter, Facebook, and LinkedIn. Wolters Kluwer has a dedicated team of experienced talent acquisition professionals who are ready to hear what makes you tick and share how Wolters Kluwer can help you achieve your goals and ambitions. Here Rasi Fawaz shares some tips on what recruiters are looking for on a resume. As a global organization, we recognize that solving a wide range of complex problems requires diverse perspectives and innovative thinking. We know that bringing our best to our customers, communities, and other key stakeholders requires a highly engaged and talented workforce – one that represents the diversity of those we serve and the communities where we live and work. We aim to provide a welcoming environment and equitable opportunities for all employees regardless of background, nationality, race, ethnicity, gender, gender identity, age, sexual orientation, marital status, disability, or religion. This principle is ingrained in our company values and articulated in our Code of Business Ethics. At Wolters Kluwer, you’ll feel valued for your contributions, and you’ll know that your health, safety, and well-being are important to us. Our well-being benefits provide tools, programs, and resources to help our diverse employees feel healthy, happy, safe, and prosperous. In 2024 we were awarded Ragan’s Top Places to Work for Employee Wellbeing: Large Organization, in recognition of our commitment to maintaining and enhancing the well-being of our colleagues through our ‘Together we thrive’ well-being program. To ensure we continue to drive innovation that enables us to develop products and services to best serve our customers, we cultivate a workplace culture rooted in mutual respect, bringing forward insights from a wide range of backgrounds, perspectives, and experiences. We are also committed to complying with laws requiring equal opportunity in hiring, promotion, and other employment decisions. All qualified applicants will receive consideration without regard to race, color, religion, sex (including pregnancy, gender identity, transgender status, and sexual orientation), national origin, disability, age, genetic information, veteran status, or any other characteristic protected by applicable law, and we do not tolerate discrimination on any of these bases. GDPR Careers Privacy and Cookies Wolters Kluwer (“we” or “us”) wants to inform you about the ways we process your personal information. In this Privacy & Cookie Notice we explain what personal information we collect, use and disclose. You'll find details related to GDPR and other data privacy policies on our Careers Privacy and Cookies page.