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Principal Regulatory Affairs Specialist (Business Partnerships).

5+ years
$98,000 – $196,000
10 July 28, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

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.