Job Summary
Abbott is hiring a Principal Regulatory Affairs Specialist – Business Partnerships for its Diabetes Care Division in Alameda, California. This on-site role focuses on strategic regulatory initiatives for global partnerships, particularly involving cloud and sensor-based medical devices. You will work with cutting-edge glucose monitoring technology, such as FreeStyle Libre, helping over 6 million people manage diabetes. Ideal for regulatory professionals experienced with Class II/III medical devices, this role offers leadership influence across international markets.
Key Responsibilities
Develop global regulatory strategies across the product lifecycle.
Create and manage project plans and timelines.
Provide strategic input and technical leadership to internal and external stakeholders.
Drive regulatory compliance for global business partnerships.
Prepare and support regulatory submissions (510(k), PMA, etc.).
Oversee labeling, SOPs, post-market requirements, and recall protocols.
Monitor changing global regulations and develop compliance solutions.
Liaise with FDA, international bodies, and regulatory teams worldwide.
Required Skills & Qualifications
Bachelor’s degree in a scientific discipline (Chemistry, Biology, Life Sciences).
Minimum 5 years’ experience with Class II/III medical devices, pharmaceuticals, or diagnostics.
Strong knowledge of FDA 21 CFR 820, ISO 13485, ICH guidelines, and EU MDR/IVDR.
Hands-on experience with 510(k) submissions, PMA supplements, and international regulations.
Proficient with regulatory documentation and technical writing.
Regulatory Affairs Certification (RAC) is a plus.
Excellent communication, project management, and problem-solving skills.
Ability to work independently and in cross-functional teams.
Perks & Benefits
Base salary: $98,000 – $196,000 (location-dependent).
Free medical coverage through HIP PPO plan.
Generous retirement savings plan with employer contributions.
Freedom 2 Save student debt program.
FreeU Education Benefit – support for obtaining a bachelor's degree.
Tuition reimbursement.
Global career development opportunities.
Employee wellness initiatives and appreciation programs.
Recognized as a top employer for diversity and innovation.
Company Description
Abbott is a global healthcare leader in diagnostics, medical devices, nutrition, and branded generics. With over 114,000 employees in 160+ countries, Abbott drives innovation in diabetes care, cardiovascular technology, and chronic disease management through life-changing products and partnerships.
Work Mode
On-site – Alameda, California, United States
Call to Action
If you're a seasoned regulatory affairs expert ready to lead strategic global partnerships and regulatory innovations in the medical device space — apply now and be part of Abbott’s mission to revolutionize diabetes care.
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