Director, Project Leadership - Compliance PM & ALD

RXinsider LTD.; Alameda (CA); Hybrid; USD 172,000 - 344,000; Full time

Benefits offered by this job

Healthcare benefits

Retirement plan

Tuition reimbursement

Education benefit

Job summary

Abbott is a global healthcare leader seeking a senior portfolio leader to own the Compliance/UDI program portfolio, drive CAPA and regulatory initiatives, and guide on-market product changes. You will develop strategies, roadmaps, and ensure alignment with regulatory priorities across multiple domains.

You will lead a global team of ~40 professionals, collaborate across Regulatory, Quality, R&D, Supply Chain, Manufacturing, and Commercial, and report to executive leadership, delivering

Qualifications

• Bachelor’s degree required.
• Minimum 7 years of program/portfolio leadership experience in a global, matrixed environment, preferably with consumer-focused medical or software products.

Responsibilities

• Lead global Compliance PM & ALD portfolio and CAPA/regulatory programs.
• Develop strategies and roadmaps aligned with priorities.
• Coordinate cross-functional programs across Regulatory, Quality, R&D, Supply Chain, and Manufacturing.
• Ensure timely delivery of milestones and governance across the portfolio.

Skills

Portfolio leadership

Cross-functional leadership

Governance & risk management

Executive leadership

Education

Bachelor’s degree

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

What You’ll Work On

Compliance / UDI Portfolio & Program Leadership

• 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.

Cross-Functional Execution

• 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.

Governance, Risk & Business Performance

• 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.

Organizational Leadership

• 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.

Required Qualifications

• 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.

Preferred Qualifications

• 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.

Abbott is an Equal Opportunity Employer, committed to employee diversity.

The base pay for this position is $172,000.00 – $344,000.00. In specific locations, the pay range may vary from the range posted.