Regulatory Affairs Manager – Diabetes Care (On-site)
Location: Alameda, California, United States
Category: Regulatory Affairs
About Abbott
Abbott is a global healthcare leader committed to enhancing lives through advanced technologies in diagnostics, medical devices, nutrition, and branded generic medicines. With a global workforce of more than 114,000 professionals across 160+ countries, Abbott continues to lead innovation in healthcare worldwide.
Working at Abbott
Abbott offers a world-class environment focused on growth, innovation, and employee well-being, including:
Comprehensive global career development opportunities
Eligibility for free medical coverage under the Health Investment Plan (HIP) PPO
Competitive retirement savings plan with strong employer contribution
Tuition reimbursement and education programs including Freedom 2 Save and FreeU
Recognition as one of the world’s most admired and inclusive companies
Abbott’s Diabetes Care Division is shaping the future of glucose monitoring with breakthrough sensing technologies. The FreeStyle Libre system has transformed diabetes management for more than six million people globally.
Position Overview
Abbott’s Diabetes Care Division in Alameda, California, is seeking a Regulatory Affairs Manager to support U.S. regulatory submissions for advanced diabetes management and digital health technologies. This role focuses on both premarket and postmarket submissions across the continuous glucose monitoring (CGM) portfolio.
The ideal candidate will have experience with insulin/drug-related solutions, 510(k) and PMA pathways, and preferably prior exposure to NDA or BLA submissions. This position serves as an influential subject-matter expert with strong strategic, technical, and regulatory leadership capabilities.
Key Responsibilities
Develop global and U.S. regulatory strategies across the full product lifecycle
Analyze regulatory outcomes, assess risks, and recommend strategic actions
Provide technical expertise and regulatory leadership on complex issues
Anticipate regulatory challenges and develop proactive solutions
Create and manage regulatory project plans and timelines
Lead cross-functional teams to prepare robust regulatory submissions
Author and review technical documentation and regulatory narratives
Manage interactions and negotiations with regulatory authorities
Review and approve product labeling for regulatory compliance
Evaluate regulatory impacts of corporate policies and emerging changes
Oversee annual registrations, listings, and license renewals
Ensure compliance with post-market surveillance and reporting requirements
Develop and maintain SOPs and systems supporting regulatory operations
Contribute to crisis/issue management processes
Provide guidance for product recalls and regulatory communications
Mentor and support junior Regulatory Affairs team members
Required Qualifications
Bachelor’s degree or equivalent combination of education and experience
4–5 years of experience in a regulated industry (medical devices or nutritionals preferred)
Higher education may offset experience requirements
2–5 years of regulatory experience, or equivalent experience in QA, R&D, scientific affairs, or operations
Strong understanding of U.S. regulatory requirements and submission processes
Excellent verbal and written communication skills
Ability to effectively collaborate with cross-functional teams
Strong attention to detail and ability to manage complex documentation
Sound judgment aligned with applicable regulations and organizational policy
Ability to analyze scientific data and identify regulatory needs
Preferred Qualifications
5+ years of experience with Class II and Class III medical devices, biologics, and/or drugs
Experience with 510(k), PMA supplements, NDA, BLA submissions
Knowledge of U.S. device, drug, biologics, and combination product regulations
Familiarity with ISO, EN standards, ICH guidelines, and QMS frameworks
Experience working in cross-division or enterprise-level environments
Ability to work independently and manage multiple priorities
Strong organizational skills and ability to meet timelines
Regulatory Affairs Certification (RAC) is an added advantage
Experience Required (Summary)
Minimum 4–5 years in a regulated industry
2–5 years directly in Regulatory Affairs or related technical fields
Experience with U.S. submissions (510(k), PMA, NDA, or BLA) strongly preferred
Prior experience with diabetes care, digital health, or drug-device combination products is an advantage
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