Senior Regulatory Affairs Specialist – Heart Failure (On-Site)
Location: Pleasanton, California, United States
Category: Regulatory Affairs
Employment Type: Full-Time, On-Site
Experience Required: 3–4 years in a regulated industry; 2–3 years in regulatory preferred
About Abbott
Abbott is a global healthcare leader driving innovations that help people live healthier, fuller lives. Our portfolio includes medical devices, diagnostics, nutritionals, and branded generics, serving millions globally. With 114,000 employees across 160+ countries, Abbott combines scientific innovation, regulatory excellence, and operational expertise to transform healthcare outcomes.
Abbott’s Heart Failure (HF) business is dedicated to helping people manage and thrive with heart failure. Through connected, lifesaving innovations, Abbott empowers patients and clinicians with seamless solutions for diagnosis, monitoring, and treatment.
Role Overview
Abbott is seeking a Senior Regulatory Affairs Specialist to join the Heart Failure team on-site in Pleasanton, CA. This position supports global regulatory strategy and ensures compliance in product registration and release processes. The specialist provides consultative guidance across business functions, assists in preparing and submitting documentation for worldwide product registration, and ensures regulatory compliance with FDA and international requirements.
Key Responsibilities
Develop and implement global regulatory strategies for new and modified products.
Prepare and submit regulatory applications including European Dossiers, Premarket Notifications, PMA Supplements, Change Notifications, and other country-specific registrations.
Serve as a regulatory representative on cross-functional product development and manufacturing teams, guiding content for submissions and participating in design reviews.
Maintain annual licenses, registrations, and product listings; ensure compliance with post-market approval requirements.
Act as Subject Matter Expert (SME) for internal and external audits and inspections.
Review, edit, and approve advertising and promotional materials for compliance.
Serve as liaison between Abbott, in-country affiliates, and regulatory authorities.
Maintain regulatory intelligence by monitoring and analyzing medical device regulations worldwide; update submission databases and inform stakeholders of changes.
Support product release processes by creating database licenses (GTS) or reviewing product release requests.
Conduct compliance reviews for product and manufacturing changes.
Collaborate across functions including Quality, R&D, Legal, Operations, and Marketing to ensure regulatory requirements are met.
Comply with FDA, international regulations, company policies, and Quality Management Systems (QMS/EMS).
Perform additional duties as assigned to support regulatory initiatives and business objectives.
Required Qualifications
Bachelor’s degree in a relevant field, or equivalent combination of education and experience.
3–4 years of experience in a regulated industry (medical devices, pharmaceuticals, or nutritionals).
2–3 years in regulatory affairs preferred; other relevant experience in quality assurance, R&D, scientific affairs, or operations may be considered.
Strong written and verbal communication skills; ability to negotiate internally and externally.
Excellent organizational, analytical, and problem-solving skills.
Ability to track and manage complex regulatory information.
Exercise ethical judgment and apply regulatory knowledge to business decisions.
Preferred Qualifications
Minimum 5 years of experience with Class II and/or Class III medical devices.
Regulatory Affairs Certification (RAC) is a plus.
Experience with 510(k) applications, PMA supplements, US device regulations, or EU/international medical device submissions.
Knowledge of Quality System standards and clinical investigations.
Experience with MS Office suite (Word, Excel, PowerPoint).
Ability to work in a matrixed, geographically diverse environment.
Demonstrated ability to work independently, solve complex regulatory issues, and mentor junior staff.
Why Join Abbott
Professional development and career growth opportunities in a global healthcare leader.
Comprehensive health and wellness benefits including medical, dental, vision, and occupational health programs.
Competitive retirement savings plans and tuition assistance.
Contribute to innovative heart failure solutions that improve patient outcomes worldwide.
Learn more: www.abbottbenefits.com
Abbott is an Equal Opportunity Employer, committed to diversity, inclusion, and employee development.
Base Salary: $86,700 – $173,300 (location-dependent)
Apply Now to join Abbott as a Senior Regulatory Affairs Specialist – Heart Failure.
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