Regulatory Affairs Manager – International Compliance Operations (On-site) | Abbott, Alameda, CA
Job Summary
Abbott, a world leader in healthcare innovation and medical devices, is hiring a Regulatory Affairs Manager – International Compliance Operations at its Diabetes Care Division in Alameda, California. This role is essential for driving global regulatory compliance operations across Abbott’s breakthrough diabetes management products, ensuring adherence to FDA, EU MDR/IVDR, and global regulatory requirements. Ideal for regulatory experts in the medical device industry who excel in risk assessment, FDA submissions, and international regulatory strategies.
Key Responsibilities
Develop and review SOPs ensuring regulatory and quality compliance.
Contribute to regional and global regulatory strategies in response to changing regulations.
Assess and interpret emerging regulatory requirements, updating stakeholders accordingly.
Support product lifecycle planning with regulatory insights and risk-benefit analysis.
Evaluate regulatory gaps and ensure documentation meets global submission standards.
Review and approve labeling content and external communications for regulatory compliance.
Provide regulatory input during product recalls and crisis management programs.
Maintain expert knowledge on FDA, ISO, QSR, and global medical device regulations.
Train staff on new and evolving global regulatory requirements.
Lead resolution of regulatory issues, preventing recurrence through process improvements.
Required Skills & Qualifications
Bachelor’s degree or equivalent in Science, Medical, Engineering, or related field.
Minimum 8 years’ experience in the medical device sector; 5+ years handling FDA submissions (PMA, IDE, 510(k)) for Class I, II, III devices.
Strong knowledge of QSR, ISO, EN standards, and global medical device regulations (EU, Japan, Canada, etc.).
Proven scientific writing and communication skills.
Proficiency in Microsoft Excel, PowerPoint, and regulatory software like Veeva Vault.
Ability to work effectively within matrixed and cross-functional teams.
Preferred Skills & Qualifications
Advanced degree in Science, Engineering, or Regulatory Affairs.
Familiarity with IVDR, pharma regulatory practices, and design control processes.
Certifications such as PMP, RAC, or LEAN are a plus.
Experience working with international authorities like ANVISA, TGA, NMPA.
Perks & Benefits
Competitive Salary Range: $112,000 – $224,000 per year.
Comprehensive health, dental, vision insurance — coverage starts on day one.
401(k) plan with excellent company match.
Tuition reimbursement and educational assistance (FreeU program).
Paid vacation, personal days, and holidays.
Career growth within a globally recognized, stable healthcare leader.
Company Description
Abbott is a global healthcare and medical device innovator committed to helping people live healthier, fuller lives. With a strong presence in over 160 countries, Abbott leads the way in diagnostics, medical devices, nutrition, and pharmaceuticals.
Work Mode
On-site — Alameda, California, United States.
Call to Action
Ready to lead global regulatory operations in a market-leading healthcare company? Apply now to join Abbott and make a meaningful impact in the diabetes care industry.
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