Director, Project Leadership - Compliance PM & ALD

• Lead the global Compliance PM & ALD portfolio, including CAPA, regulatory compliance, labeling changes, on market product changes, and UDI initiatives.

• Develop and execute portfolio strategies, roadmaps, and plans aligned with business and regulatory priorities.

• Oversee interconnected programs, ensuring alignment of resources, timelines, risks, and deliverables.

• Drive successful execution through governance, risk management, and operational excellence.

• Assess business, supply, compliance, and strategic impacts of key decisions.

• Lead global cross-functional programs across Regulatory, Quality, R&D, Supply Chain, Manufacturing, Commercial, and external partners.

• Coordinate labeling, artwork, manufacturing, procurement, registration, and product launch activities.

• Ensure delivery of key milestones, regulatory commitments, and business objectives.

• Facilitate decisions, resolve issues, and manage program dependencies.

• Establish portfolio governance and provide visibility into status, risks, resources, and business impact.

• Drive proactive risk management and executive decision support across the portfolio.

• Manage budgets, resource planning, and continuous improvement initiatives to enhance efficiency and scalability.

• Lead and develop a global team of ~40 Program Managers, Project Managers, Labeling Specialists, and contingent workers.

• Foster accountability, collaboration, talent development, and continuous improvement.

• Strengthen organizational capability through coaching, succession planning, and PMO best practices.

• Represent the function in executive reviews, business planning, and leadership forums.

• Bachelor’s degree

• Minimum 7 years experience in program/portfolio leadership within a global, matrixed team, preferably including experience with consumer-focused medical or software products.

• Cross-functional experience in the areas of R&D, Commercial, Clinical, Regulatory, Quality, and Manufacturing

• Knowledge of regulations and standards related to medical devices (eg FDA, ISO, QSR design controls).

• Demonstrated ability to lead enterprise-level portfolios and influence senior stakeholders, and to collaborate effectively with global stakeholders across multiple time zones.

• Deep expertise in governance design, operating models, and portfolio prioritization

• Strong executive communication and decision-making skills

• Proven track record of building and developing high-performing teams

• Experience with portfolio management tools and reporting frameworks preferred

• Demonstrated ability to work with a wide variety of people at all levels of the organization

• Strong leadership, and the ability to collect information from multiple sources, and synthesize, integrate, and resolve conflicting requirements and cross-functional issues.

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