Senior Regulatory Project Management Specialist

Regulatory Jobs; Santa Clara (CA); Sur place; USD 90 000 - 180 000; Plein temps

Avantages offerts par ce poste

Health insurance

Retirement plan with employer matching

Tuition reimbursement

Education benefit – FreeU

Résumé du poste

Abbott is a global healthcare leader delivering life-changing technologies across diagnostics, devices, and nutrition. This Senior Regulatory Project Management Specialist role coordinates complex regulatory initiatives in global markets, collaborating with Regulatory Affairs, R&D, Quality, and Operations to ensure timely submissions and registrations.

You will plan, monitor, and report on milestones, navigate cross-geo teams, and drive alignment to accelerate product approvals while ensuring

Qualifications

• Bachelor’s degree required.
• Minimum 5 years of project management experience.
• Experience in regulatory, quality, or product management in medical devices preferred.

Responsabilités

• Lead planning, coordination, and execution of global regulatory projects for product registrations and lifecycle management.
• Develop detailed project plans, timelines, milestones, and tracking tools.
• Coordinate with Regulatory Affairs, R&D, Quality, Clinical, Operations, and other teams.
• Monitor progress, identify risks, issues, and resource constraints; implement mitigation plans.
• Facilitate cross-functional meetings; assign ownership and drive accountability.
• Communicate project status and metrics to stakeholders and leadership regularly.
• Support multiple concurrent projects across geographies, balancing priorities.
• Coordinate inputs to support budget cycles and project decisions.

Connaissances

Project management

Cross-functional collaboration

Formation

Bachelor’s degree

Description du poste

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 122,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

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.

The Opportunity

Division: Leverage Services – Global Regulatory Services

Location: Santa Clara, CA, Sylmar, CA, Temecula, CA, or St Paul, MN

The Senior Regulatory Project Management Specialist will play a critical role in driving the successful execution of business-critical global regulatory initiatives across Abbott's medical device portfolio. Working in close partnership with cross-functional teams, the international regulatory affairs organization, and business unit stakeholders, this role will help coordinate and manage complex projects supporting regulatory submissions and product registrations in key global markets.

This position serves as a central point of coordination for project planning, execution, monitoring, and reporting, ensuring that critical milestones, deliverables, risks, and dependencies are proactively managed. The role requires strong project management, communication, and stakeholder engagement skills to drive alignment across diverse teams and support timely delivery of regulatory objectives that enable business growth and patient access worldwide. Success in this role requires the ability to navigate complex, fast-paced environments, influence without direct authority, and bring structure and accountability to cross-functional initiatives spanning multiple geographies and business functions.

What You'll Work On

• Lead the planning, coordination, and execution of global regulatory projects supporting product registrations, submissions, approvals, and lifecycle management activities across international markets.
• Develop and maintain detailed project plans, timelines, milestones, and tracking tools to ensure project deliverables are completed on schedule and aligned with business priorities.
• Partner closely with Regulatory Affairs, R&D, Quality, Clinical, Operations, and other functional teams to coordinate activities and ensure successful project execution.
• Monitor project progress, identify risks, issues, and resource constraints, and drive mitigation plans to minimize delays and maintain project momentum.
• Facilitate cross-functional meetings, establish action plans, assign clear ownership, and follow through on key deliverables to ensure accountability and execution.
• 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 various geographies, balancing competing priorities while maintaining a strong focus on execution and results.
• Coordinate inputs to support financial budget cycle activities and project decisions

Required Qualifications

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

Preferred Qualifications

• 6+ years relevant experience in regulatory, quality, or product management in medical device industry.
• Experience with OUS / International medical device product registrations.
• Demonstrated ability to manage all aspects of 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.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://abbottbenefits.com/

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.

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

Connect with us at https://www.abbott.com/ , on LinkedIn at https://www.linkedin.com/company/abbott-/ , and on Facebook at https://www.facebook.com/AbbottCareers .

The base pay for this position is

$90,000.00 – $180,000.00

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Project Management

DIVISION:

MD Medical Devices

LOCATION:

United States > Santa Clara : Building B - SC

ADDITIONAL LOCATIONS:

United States > Minnesota > St. Paul > Lillehei : One Lillehei Plaza, United States > Sylmar : 15900 Valley View Court, United States > Temecula : Building E - TE

WORK SHIFT:

Standard

TRAVEL:

Yes, 10 % of the Time

MEDICAL SURVEILLANCE:

No

SIGNIFICANT WORK ACTIVITIES:

Awkward/forceful/repetitive (arms above shoulder, bent wrists), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf