Senior Regulatory Project Management Specialist (on-site)

Abbott • Santa Clara, SC

4d • Onsite

About The Position

The Senior Regulatory Project Management Specialist will drive the execution of business-critical global regulatory initiatives across Abbott’s medical device portfolio. In partnership with cross-functional teams, the international regulatory affairs organization, and business unit stakeholders, this role coordinates and manages complex projects that support regulatory submissions and product registrations in key global markets. The specialist is a central point of coordination for project planning, execution, monitoring, and reporting, proactively managing milestones, deliverables, risks, and dependencies. The role requires strong project management, communication, and stakeholder engagement skills to align diverse teams and support timely delivery of regulatory objectives that enable business growth and patient access worldwide. Success requires navigating complex, fast-paced environments, influencing without direct authority, and bringing structure and accountability to cross-functional initiatives across geographies and business functions. The position is based on-site in Santa Clara, Sylmar, or Temecula, California, or St. Paul, Minnesota, with travel approximately 10% of the time.

Requirements

• Bachelor’s degree.
• Minimum 5 years of project management or related experience.

Nice To Haves

• 6 or more years of relevant experience in regulatory, quality, or product management in the medical device industry.
• Experience with OUS or international medical device product registrations.
• Demonstrated ability to manage large-scale, complex projects from start to finish.
• Experience developing project plans, schedules, budgets, forecasts, and resource plans.
• Ability to coordinate cross-functional resources and manage project execution to achieve objectives.
• Experience conducting project meetings, tracking progress, and communicating project status through reports and stakeholder updates.
• Ability to manage meetings across global time zones on a regular basis.

Responsibilities

• Lead planning, coordination, and execution of global regulatory projects supporting product registrations, submissions, approvals, and lifecycle management activities across international markets.
• Develop and maintain project plans, timelines, milestones, and tracking tools to ensure deliverables are completed on schedule and aligned with business priorities.
• Partner with Regulatory Affairs, R&D, Quality, Clinical, Operations, and other functional teams to coordinate activities and execute projects successfully.
• Monitor project progress, identify risks, issues, and resource constraints, and drive mitigation plans to minimize delays and maintain momentum.
• Facilitate cross-functional meetings, establish action plans, assign ownership, and follow through on deliverables to ensure accountability.
• Track and communicate project status, critical-path activities, key decisions, and metrics to stakeholders and leadership through regular reporting and project reviews.
• Support multiple concurrent projects across geographies, balancing competing priorities while maintaining focus on execution and results.
• Coordinate inputs to support financial budget-cycle activities and project decisions.

Benefits

• Career development opportunities with an international company.
• Employees may qualify for free medical coverage in the Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• Retirement savings plan with a high employer contribution.
• Tuition reimbursement.
• Freedom 2 Save student debt program.
• FreeU education benefit, offering an affordable and convenient path to a bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior