Lead Project & Program Manager: Delivery and Portfolio Office Enablement and Medical Device Enablement

About the Role
Wolters Kluwer Health is seeking a highly experienced Lead Project & Program Manager to drive complex, cross-functional initiatives that enhance the organization's capability to develop, launch, and sustain medical device products. This role will oversee a strategic portfolio of enablement programs spanning Operations Enablement, Quality, Regulatory Affairs, Clinical, Operations, Product, Commercial, and Technology functions.
The successful candidate will be responsible for building and executing integrated project plans, aligning stakeholders across the business, managing risks and dependencies, and ensuring successful adoption of new processes, systems, and ways of working. A key objective of this role is to continuously improve the organization's medical device delivery capabilities while maintaining the highest standards of quality, compliance, and operational readiness.
Key Responsibilities
Lead and manage a portfolio of medical device enablement programs, coordinating multiple cross-functional workstreams, dependencies, milestones, and outcomes.
Develop and maintain comprehensive project plans that clearly define scope, timelines, governance structures, resource requirements, risks, dependencies, and success metrics.
Drive Quality Management System (QMS) migration, enhancement, and optimization initiatives, ensuring organizational readiness, training effectiveness, stakeholder alignment, and user adoption.
Collaborate closely with Quality, Regulatory Affairs, Clinical, Operations, Product, Commercial, and Technology teams to align program execution with business objectives and regulatory requirements.
Facilitate cross-functional planning, requirements gathering, prioritization, decision-making, and issue-resolution activities across a complex matrix organization.
Prepare and deliver executive-level reporting, portfolio updates, risk assessments, and decision-support materials for senior leadership.
Proactively manage project constraints, including budget, resources, timelines, operational impacts, and regulatory considerations.
Identify and implement opportunities to improve planning processes, execution discipline, governance, handoffs, and continuous improvement practices throughout the medical device lifecycle.
Support organizational change management efforts, driving adoption of new processes, quality standards, tools, and operating models.
Foster a culture of accountability, collaboration, continuous improvement, and operational excellence.
Required Qualifications
Education
Bachelor's degree in Business, Engineering, Life Sciences, Healthcare, or a related discipline is preferred.
Advanced degree is a plus.
Experience
Significant experience leading complex project and program management initiatives within large, cross-functional, and matrixed organizations.
Proven experience delivering business transformation, operational excellence, or enterprise change programs.
Experience working within regulated industries such as medical devices, life sciences, healthcare, pharmaceuticals, or other highly regulated environments.
Demonstrated success managing integrated project plans with multiple workstreams, stakeholders, dependencies, and competing priorities.
Strong track record of managing governance forums, risk mitigation, resource planning, budgets, timelines, and executive communications.
Exceptional stakeholder management, communication, presentation, facilitation, and organizational skills.
Experience working with global teams, executive stakeholders, and third-party vendors.
Practical understanding of Agile methodologies and the ability to apply Agile principles effectively within business and operational environments.
Preferred Qualifications
Project Management Professional (PMP) certification strongly preferred.
Direct experience supporting medical device development, enablement, quality systems, regulatory compliance, or product lifecycle management initiatives.
Experience leading Quality Management System (QMS) implementations, migrations, or transformation programs.
Agile certification (Scrum Master, SAFe, AgilePM, or equivalent) or demonstrated success applying Agile practices in cross-functional initiatives.
Familiarity with medical device regulations, quality systems, and compliance frameworks.
Success Profile
The ideal candidate is a strategic and hands-on program leader who excels in navigating ambiguity, influencing without authority, and delivering results in highly regulated environments. They are equally comfortable engaging executive stakeholders, managing detailed project execution, and driving sustainable organizational change that improves medical device delivery performance.
Key competencies include:
Strategic Program Leadership
Cross-functional Stakeholder Management
Change Management & Adoption
Risk & Dependency Management
Continuous Improvement
Executive Communication
Regulatory & Quality Awareness
Agile Delivery Practices
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.