New · posted Nov 6
Abbott · Medical Devices
Senior Regulatory Project Management Specialist
- Santa Clara, CA +1 more
- On-site
- Full-time
- Senior & Principal
The role
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.
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.
What you need
Required Qualifications
- Bachelor’s degree.
- Minimum 5 years of project management or related experience.
Preferred Qualificationsnice to have
- 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.
What you'll do
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
Pay and benefits
$90,000 – $180,000 a year
Employer providedThe base pay for this position is
$90,000.00 – $180,000.00
In specific locations, the pay range may vary from the range posted.
Free medical coverage option (Health Investment Plan PPO)
Retirement savings plan with high employer contribution
Tuition reimbursement
Freedom 2 Save student debt program
FreeU education benefit
Career development
Where you'll work
Santa Clara, CA +1 moreOn-siteOpen in Maps (opens in a new tab)
Also posted for: Santa Clara, CA (also Sylmar, Temecula, CA · St. Paul, MN)
More jobs in Santa Clara, CA +1 moreWorking conditions
Standard
TRAVEL
Yes, 10 % of the Time
MEDICAL SURVEILLANCE
No
Apply Now
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.
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 .
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
Division: Leverage Services – Global Regulatory Services
From the posting
About Abbott
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.
Equal opportunity, accessibility and legal noticesAbbott's statements, word for word
Abbott is an Equal Opportunity Employer, committed to employee diversity.
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
Job intelligence
The context around this role
Live data · November 6, 2026
Salary intelligence
How the pay compares
This roleEmployer provided
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $90,000 | — | $180,000 |
This role: Abbott's own published range.
Career trajectory
Where this role sits in Regulatory Project Management
The general path across 20 open Regulatory Project Management roles on Regulatory Jobs, with the titles they carry most. Not Abbott's own promotion track.
Career resources on Regulatory Project Management
Skills DNA
What this role leans on
How many of the posting's 20 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership10
- Regulatory submissions2
- Documentation and SOPs1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Regulatory Project Management work in medical devices, each linked to the agency or standards body that publishes it.
- FDAFDA 510(k)(official source, opens in a new tab)Premarket notification: showing substantial equivalence to a legally marketed device
- FDA21 CFR Part 814(official source, opens in a new tab)Premarket approval of class III medical devices
- FDAFDA De Novo(official source, opens in a new tab)Classification requests for novel low- to moderate-risk devices
- FDAFDA Q-Submission Program(official source, opens in a new tab)Pre-Submissions and meetings with FDA on device submissions
- FDAFDA eSTAR(official source, opens in a new tab)The electronic submission template for 510(k) and De Novo requests
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
- EUEU IVDR (Regulation 2017/746)(official source, opens in a new tab)The EU In Vitro Diagnostic Medical Devices Regulation
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices, aligned with ISO 13485
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devices
- FDA21 CFR Part 812(official source, opens in a new tab)Investigational device exemptions for clinical studies of devices
- FDA21 CFR Part 807(official source, opens in a new tab)Establishment registration, device listing and premarket notification
- FDA21 CFR Part 801(official source, opens in a new tab)FDA labeling requirements for medical devices
- EUMDCG guidance(official source, opens in a new tab)The Medical Device Coordination Group's endorsed guidance on applying the MDR and IVDR
- FDA21 CFR Part 830 (UDI)(official source, opens in a new tab)Unique device identification and the GUDID database
- Health CanadaCanada Medical Devices Regulations(official source, opens in a new tab)Health Canada's licensing and quality requirements for medical devices (SOR/98-282)
Company hiring pulse
Abbott on Regulatory Jobs
- 108
- Open roles
- 108
- Distinct roles
- 33
- Locations
By discipline
- Quality56 51%
- Regulatory30 28%
- Clinical22 20%
By level
- Senior & Principal51 47%
- Associate & Specialist31 28%
- Manager23 21%
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Senior Regulatory Project Management Specialist at Abbott
Open until filled. $90K–$180K a year, employer provided.