Senior Regulatory Project Management Specialist (on-site)

1030 Abbott Cardiovascular Sys Inc; Santa Clara (CA); In loco; USD 90.000 - 180.000; Tempo pieno

Vantaggi offerti da questo lavoro

Career development

HIP PPO medical plan

Retirement plan with high employer<br>

Tuition reimbursement

FreeU education benefit

Descrizione del lavoro

Abbott in Santa Clara, CA, is seeking a Senior Regulatory Project Management Specialist to drive global regulatory initiatives for its medical device portfolio. You will coordinate cross-functional teams, manage regulatory submissions across international markets, and ensure on-time delivery of milestones in a fast-paced environment.

We value strong project management, stakeholder engagement, and the ability to navigate complex regulatory landscapes to enable growth and patient access worldwide.

Competenze

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

Mansioni

• Lead the planning, coordination, and execution of global regulatory projects for product registrations, submissions, and lifecycle management across international markets.
• Develop and maintain detailed project plans, timelines, milestones, and tracking tools to ensure timely delivery.
• Coordinate with Regulatory Affairs, R&D, Quality, Clinical, Operations, and other teams to ensure project success.

Conoscenze

Project management

Regulatory affairs

Cross-functional collaboration

Stakeholder communication

Formazione

Bachelor’s degree

Descrizione del lavoro

About Abbott

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.

Working at Abbott

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.

Opportunity Division: Leverage Services - Global Regulatory Services

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

Senior Regulatory Project Management Specialist

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.

Compensation

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 & Division

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 & Travel

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).

Equal Opportunity

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO Links

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

About Abbott – Company Culture

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential - because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions - across the spectrum of health, around the world, for all stages of life. Whether it's next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life's greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings.

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

Contact & Follow

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

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