Senior Regulatory Affairs Specialist (On-site, Santa Clara, CA)
Job Summary
Abbott’s Vascular Division in Santa Clara, CA is hiring a Senior Regulatory Affairs Specialist to drive regulatory strategies, submissions, and compliance for innovative vascular medical devices. The role will oversee product lifecycle planning, regulatory risk assessments, pre-market and post-market activities, and global registration submissions to ensure adherence to FDA and international standards.
Key Responsibilities
Provide regulatory input for product lifecycle planning and strategic development.
Develop and update regional and global regulatory strategies based on evolving regulations.
Assess preclinical, clinical, and manufacturing data for regulatory submissions.
Prepare, review, and submit robust regulatory filings (PMA, IDE, international submissions).
Collaborate with regulatory agencies to ensure smooth development and review processes.
Monitor and ensure compliance with post-market approval requirements.
Manage annual licenses, product listings, and regulatory reports.
Evaluate change controls and labeling for regulatory compliance.
Contribute to risk-benefit analyses and ensure timely reporting of product safety issues.
Provide regulatory support for product recalls and external communications.
Required Skills & Qualifications
Bachelor's Degree in a science or technical discipline or equivalent education/experience.
3-4 years of experience in a regulated industry (medical devices, nutritionals, etc.).
2-3 years in regulatory affairs preferred (will consider quality assurance, R&D, scientific affairs).
Strong knowledge of FDA and international medical device regulations.
Excellent verbal and written communication skills.
Strong organizational, follow-up, and detail-orientation abilities.
Capable of managing multiple projects and priorities.
Ability to analyze scientific data and solve regulatory issues under guidance.
Preferred Qualifications
Master’s degree in a technical/science field.
Certification (such as RAC from the Regulatory Affairs Professionals Society) is a plus.
Previous experience with PMA, IDE, and international regulatory submissions.
Knowledge of IDE trial strategies and post-market clinical activities.
Prior experience in the medical device industry.
Perks & Benefits
Salary Range: $86,700 – $173,300 annually.
Free medical coverage under the Health Investment Plan (HIP) PPO.
Excellent retirement savings plan with generous employer contributions.
Tuition reimbursement, Freedom 2 Save student loan program, and FreeU bachelor’s degree benefit.
Global career development opportunities within a Fortune-recognized healthcare leader.
Company Description
Abbott is a global healthcare leader offering innovative solutions in diagnostics, medical devices, pharmaceuticals, and nutrition. Its Vascular Division develops minimally invasive, cost-effective treatments for vascular diseases worldwide.
Work Mode
On-site – Santa Clara, California, United States
Call to Action
Ready to lead regulatory affairs for cutting-edge vascular medical devices? Apply now to shape the future of healthcare innovations with Abbott.
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