Abbott – Principal Regulatory Affairs Specialist (Business Partnerships)
Location: Alameda, CA
Division: Diabetes Care
Salary Range: $98,000 – $196,000 (may vary by location)
About Abbott
Abbott is a global healthcare leader dedicated to helping people live fully at every stage of life. Our portfolio spans diagnostics, medical devices, nutritionals, and branded generic medicines. With 114,000 colleagues, we serve people in more than 160 countries.
At Abbott, you can:
Do work that matters and grow your career globally.
Access free medical coverage via the Health Investment Plan (HIP) PPO medical plan (eligibility next calendar year).
Benefit from an excellent retirement plan with high employer contributions.
Take advantage of tuition reimbursement, Freedom 2 Save student debt program, and FreeU education benefits.
Work for a company recognized globally for diversity, inclusion, and innovation in healthcare.
Abbott is particularly committed to helping people with diabetes manage their health through innovative products like the FreeStyle Libre continuous glucose monitor, transforming the lives of millions worldwide.
Position Summary
The Principal RA Specialist – Business Partnerships will be based on-site in Alameda, CA, within the Diabetes Care Division. This role focuses on regulatory strategy for strategic business initiatives globally, including Cloud/Sensor-based external partnerships.
This position requires:
Department-level influence
Experience in global regulatory submissions and on-market changes
Recognition as a regulatory expert internally and externally
The role involves monitoring regulations, developing compliance strategies, liaising with regulatory agencies, and providing executive-level regulatory metrics.
Key Responsibilities
Regulatory Strategy & Leadership
Develop global regulatory strategies throughout the product lifecycle.
Analyze regulatory outcomes and recommend strategic actions.
Provide technical leadership and guidance on complex regulatory issues.
Anticipate regulatory obstacles and emerging issues, developing solutions with cross-functional teams.
Project Management & Compliance
Create project plans and timelines for regulatory submissions.
Support functional teams in developing data for submissions.
Write, review, and edit regulatory documents.
Ensure compliance with regulatory requirements and labeling standards.
Partnership & Risk Management
Act as regulatory liaison internally and externally.
Evaluate regulatory risks of corporate policies and business partnerships.
Oversee post-market compliance and product-associated event tracking.
Contribute to crisis/issue management and product recall processes.
Required Qualifications
Bachelor’s degree in a scientific discipline (e.g., Chemistry, Life Sciences, Biology) or equivalent vocational qualification.
Experience in regulatory submissions for pharmaceuticals, in vitro diagnostics, or medical devices.
Knowledge of 21 CFR 820, ISO 13485, Medical Devices Directive (93/42/EEC), and/or IVD Directive (98/79/EC).
Preferred Qualifications
5+ years’ experience with Class II/III medical devices, biologics, or drugs.
Regulatory Affairs Certification (RAC) is a plus.
Experience with 510(k) applications, PMA supplements, US, EU, and international medical device regulations.
Familiarity with clinical investigations, Quality Systems standards, and ICH guidelines.
Proficiency in Microsoft Office Suite and presentation software.
Experience working in matrixed, cross-division, global environments.
Strong communication, problem-solving, organizational, and multitasking skills.
Ability to travel ~5% (including international).
Why Abbott
Diverse career growth opportunities in a global healthcare leader.
Comprehensive health and wellness benefits.
Recognized as a great place to work for diversity, inclusion, and innovation.
Learn more about benefits: www.abbottbenefits.com
Connect with Abbott:
Website: www.abbott.com
Facebook: facebook.com/Abbott
Twitter: @AbbottNews | @AbbottGlobal
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