Position Title:
Regulatory Affairs Manager – Diabetes Care (On-site)
Location:
Alameda, California, USA
Department:
Regulatory Affairs
Company Overview:
Abbott is a global healthcare leader dedicated to improving lives through innovative technologies and life-changing products across Diagnostics, Medical Devices, Nutritionals, and Branded Generic Medicines.
Over 114,000 employees in 160+ countries
Recognized globally as one of the most admired companies and best places to work (for diversity, women, and scientists).
Abbott’s Diabetes Care Division empowers people to live active lives by delivering technologies like the FreeStyle Libre Continuous Glucose Monitoring System, revolutionizing diabetes management for over 6 million users worldwide.
The Opportunity:
This on-site role in Alameda, CA focuses on US regulatory submissions related to continuous glucose monitoring systems and digital health technologies.
The RA Manager will support Premarket and Postmarket submissions, influencing product strategies and ensuring regulatory compliance throughout the product lifecycle.
Key Responsibilities:
Regulatory Strategy & Submissions
Develop global regulatory strategies for new and existing products.
Prepare and manage 510(k), PMA supplements, NDA, and BLA submissions.
Anticipate and address regulatory challenges throughout the product lifecycle.
Create and maintain project plans, timelines, and compliance documents.
Lead and coordinate data collection and documentation for regulatory submissions.
Negotiate with regulatory authorities to ensure timely approvals.
Compliance & Quality Oversight
Ensure full compliance with FDA, ISO, and ICH guidelines.
Manage post-market requirements, including licenses, registrations, and safety reporting.
Support product recalls, labeling reviews, and crisis management programs.
Develop and implement SOPs to ensure tracking and reporting of product events.
Leadership & Collaboration
Serve as a technical and strategic resource within the regulatory team.
Mentor and train junior RA professionals.
Collaborate cross-functionally with R&D, QA, Clinical, and Operations teams.
Provide regulatory intelligence and communicate metrics to executive leadership.
Required Qualifications:
Bachelor’s degree (Life Sciences, Pharmacy, Biomedical, or related field).
4–5 years of experience in a regulated industry (medical products, nutritionals, etc.).
2–5 years of experience in Regulatory Affairs (or related functions like QA, R&D).
Strong verbal and written communication and negotiation skills.
Excellent attention to detail, organization, and project management.
Ability to work effectively in cross-functional teams and independently.
Sound ethical judgment and understanding of scientific data needs.
Preferred Qualifications:
5+ years with Class II / III medical devices, biologics, or drug products.
Regulatory Affairs Certification (RAC) preferred.
Experience with 510(k), PMA, NDA, and BLA processes.
Working knowledge of:
FDA Device/Drug/Biologic Regulations
US Combination Product Regulations
ISO & EN Standards
ICH Guidelines and Quality Systems Standards
Proficient in MS Office (Word, Excel, PowerPoint).
Strong problem-solving, multitasking, and leadership abilities.
Experience working in matrixed, cross-division environments.
Compensation & Benefits:
Base Pay Range: $112,000 – $224,000 (may vary by location).
Health Investment Plan (HIP): Free medical coverage eligibility.
Retirement Savings Plan: High employer contributions.
Education Support:
Tuition reimbursement
Freedom 2 Save student debt program
FreeU bachelor’s degree pathway
Global Career Development Opportunities
Recognition as a Top Employer for Diversity and Inclusion
Application & Contact:
🔗 Apply Now: www.abbottbenefits.com
🌐 Learn more: www.abbott.com
📱 Connect:
Facebook: facebook.com/Abbott
Twitter: @AbbottNews | @AbbottGlobal
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