Job Title: Senior Regulatory Affairs Specialist – Heart Failure (On-site)
Location: Pleasanton, California, United States
Category: Regulatory Affairs
About Abbott
Abbott is a global healthcare leader helping people live more fully at all stages of life. Its portfolio spans diagnostics, medical devices, nutritionals, and branded generic medicines, with 114,000 employees serving in over 160 countries.
Working at Abbott
At Abbott, you’ll do work that matters while growing personally and professionally.
Key Benefits & Opportunities:
Career development with a global organization.
Free medical coverage (Health Investment Plan – HIP PPO) for eligible employees.
Excellent retirement savings plan with high employer contribution.
Tuition reimbursement, Freedom 2 Save student debt program, and FreeU bachelor’s degree benefit.
Recognized as a top workplace globally (Fortune “Most Admired Companies”, best for diversity, working mothers, and scientists).
Heart Failure Business Overview
Abbott’s Heart Failure (HF) business is dedicated to helping people with heart failure survive and thrive through innovative technologies that support diagnosis, monitoring, and treatment. The goal is to empower patients to manage their health through connected clinical solutions.
Position Overview
As a Senior Regulatory Affairs Specialist, you will support regulatory operations to ensure compliance and efficiency. You will partner across functions to identify, collect, and prepare data for worldwide product registrations and oversee submission processes.
Key Responsibilities
Develop worldwide regulatory strategies for new and modified products.
Prepare and coordinate robust regulatory submissions (e.g., PMA Supplements, 510(k), European Dossiers, Change Notifications).
Represent Regulatory Affairs in cross-functional product development and manufacturing teams.
Guide teams on submission content and participate in design reviews.
Maintain annual licenses, registrations, and listings.
Ensure compliance with post-marketing approval requirements.
Serve as Subject Matter Expert (SME) during audits and inspections.
Review, edit, and approve Advertising and Promotional materials.
Act as a liaison between Abbott, regulatory agencies, and in-country affiliates.
Stay current on global medical device regulations and update internal databases.
Support Quality Management Systems (QMS) and Environmental Management Systems (EMS).
Review product and manufacturing changes for regulatory compliance.
Maintain effective communication and collaboration across internal and external stakeholders.
Perform additional regulatory duties as assigned.
Required Qualifications
Bachelor’s Degree in a related field OR equivalent education and work experience.
3–4 years of experience in a regulated industry (medical devices, nutritionals, etc.).
2–3 years in regulatory affairs preferred (may also consider QA, R&D, scientific affairs, or operations).
Strong verbal and written communication skills for internal and external regulatory discussions.
Excellent organizational, analytical, and follow-up skills.
Ability to exercise sound ethical judgment and interpret policies and regulations.
Capable of managing and tracking complex projects and data.
Understanding of scientific arguments and ability to identify regulatory data needs.
Preferred Qualifications
5+ years experience with Class II and/or Class III medical devices.
Regulatory Affairs Certification (RAC) preferred.
Experience with FDA (510(k), PMA) and EU/international device submissions.
Familiarity with Quality System Regulations and clinical investigation requirements.
Proficiency in MS Office (Word, Excel, PowerPoint).
Experience in a cross-division or matrixed organization preferred.
Ability to work independently and as part of a fast-paced team.
Strong multitasking and problem-solving abilities.
Compensation
Base Pay Range: $86,700.00 – $173,300.00 (varies by location).
What Abbott Offers
Competitive pay, incentives, and retirement benefits.
Health, dental, vision, and wellness programs.
Paid time off and work-life balance.
Long-term stability and community involvement.
Learn more at 👉 www.abbottbenefits.com
Equal Opportunity Employer
Abbott is committed to diversity and inclusion in the workplace. All qualified applicants will receive equal consideration for employment.
Connect with Abbott
🌐 www.abbott.com
📘 Facebook: Abbott
🐦 Twitter: @AbbottNews | @AbbottGlobal
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