Regulatory Affairs Manager – International Compliance Operations
Location: Alameda, California
Company: Abbott
Job Type: Full-Time
Work Mode: On-site
Salary Range: $112,000 – $224,000 (based on location and experience)
Job Summary
Abbott is hiring a Regulatory Affairs Manager – International Compliance Operations for its Diabetes Care Division in Alameda, CA. This on-site role is ideal for professionals experienced in medical device compliance, global regulatory strategy, and FDA submissions. As part of Abbott’s commitment to transforming diabetes management, you will ensure efficient and compliant regulatory processes across international markets while supporting life-changing technologies that empower better health outcomes.
Key Responsibilities
Develop and review regulatory SOPs and global compliance strategies
Interpret and implement international medical device regulations (FDA, ISO, EU MDR)
Oversee product lifecycle planning from a regulatory perspective
Support submissions such as PMA, IDE, and 510(k) for Class I–III devices
Provide regulatory input for product recalls, labeling, and risk assessments
Lead gap assessments and monitor emerging global regulatory requirements
Ensure compliance with QSR, ISO, and international standards (ANVISA, TGA, NMPA)
Coordinate regulatory crisis management and issue resolution
Collaborate cross-functionally with QA, R&D, and external stakeholders
Maintain expert knowledge of global regulations and quality systems
Required Skills & Qualifications
Bachelor’s degree or equivalent in science, engineering, or related discipline
Minimum 8 years of regulatory experience in the medical device industry
At least 5 years of experience preparing FDA submissions (PMA, IDE, 510(k))
Proven knowledge of QSR, ISO, EN, and global regulatory frameworks
Experience with IVD regulations, design controls, and global submissions
Proficiency in Veeva Vault, Microsoft Excel, and PowerPoint
Strong communication, organizational, and scientific writing skills
Preferred: Advanced degree, PMP or RAC certification
Perks & Benefits
Competitive base salary: $112,000 – $224,000
Free HIP PPO medical coverage for eligible employees
Retirement plan with high employer contribution
Tuition reimbursement and Freedom 2 Save debt program
FreeU program for completing a bachelor’s degree
Career advancement in a Fortune-recognized global company
Inclusive culture supporting diversity and development
Recognition as a top employer for scientists, women, and executives
Company Description
Abbott is a global healthcare leader driving innovation in diagnostics, nutrition, medical devices, and branded generics. With 114,000+ employees in over 160 countries, Abbott empowers people to live healthier, fuller lives through science-backed, transformative technologies.
Work Mode
On-site – Alameda, California
Call to Action
Are you a regulatory expert ready to lead global compliance in a world-class healthcare company? Apply now to join Abbott’s mission to change the future of diabetes care.
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