Job Summary
Abbott’s Vascular Division is seeking a Senior Regulatory Affairs Specialist to join its on-site team in Santa Clara, CA. This high-impact role supports global product registrations, regulatory strategy development, and compliance with FDA, EU MDR, and international standards. This opportunity is ideal for regulatory professionals with 3–4 years of experience in medical devices or other regulated industries who are passionate about improving patient outcomes through cutting-edge vascular technologies.
Key Responsibilities
Provide regulatory input into product lifecycle and regional strategy planning.
Develop, review, and submit regulatory documentation including 510(k), PMA, IDE, and international submissions.
Monitor changing regulations and assess their impact on global submission strategies.
Evaluate and prepare responses to product changes and associated regulatory filings.
Serve as liaison between Abbott and global regulatory authorities.
Maintain licenses, registrations, listings, and technical documentation (EU MDR).
Participate in post-market activities including label review, product change assessments, and recalls.
Assess external communications and contracts for regulatory compliance.
Review change controls for submission implications and maintain regulatory databases.
Required Skills & Qualifications
Bachelor’s degree in a related scientific or technical field (life sciences, engineering preferred).
3–4 years of experience in a regulated industry; 2–3 years in regulatory affairs preferred.
Experience with FDA submissions (510(k), PMA, IDE) and international product registrations.
Familiarity with EU MDR technical documentation and post-market requirements.
Strong written and verbal communication skills for interaction with regulatory authorities.
Ability to track complex data and documentation with strong attention to detail.
Excellent time management and multitasking capabilities.
Experience in a matrixed, fast-paced environment with cross-functional collaboration.
Certification (e.g., RAC) is a plus.
Perks & Benefits
Competitive base salary: $86,700 – $173,300
Free medical coverage via Health Investment Plan (HIP) PPO
High-contribution employer retirement savings plan
Tuition reimbursement and student debt assistance via Freedom 2 Save program
Free access to undergraduate degrees through FreeU benefit
Global career development with internal mobility opportunities
Inclusive, diverse, and recognized workplace culture
Company Overview
Abbott is a global healthcare company with over 114,000 employees across 160+ countries, delivering innovation in diagnostics, medical devices, branded generics, and nutritional products. The Vascular Division in Santa Clara focuses on minimally invasive devices for treating vascular disease, including drug-eluting stents, guide wires, and advanced imaging software. Abbott is consistently named a top workplace for diversity, women, STEM, and healthcare professionals.
Work Mode
On-site – Santa Clara, California, United States
Call to Action
Advance your career in regulatory affairs by joining a world-class team at Abbott Vascular. Be part of innovations that save lives and shape the future of global healthcare. Apply today to help drive regulatory excellence in medical devices.
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