Senior Regulatory Affairs Specialist – Abbott Vascular (On-site)
Location: Santa Clara, California
Company: Abbott Laboratories – Vascular Division
Work Mode: On-site
Employment Type: Full-Time
Salary Range: $86,700 – $173,300 (location-based variation may apply)
Job Summary
Abbott, a world leader in healthcare and medical technology, is hiring a Senior Regulatory Affairs Specialist to support its Vascular Division in Santa Clara, California. This role offers a unique opportunity to lead and manage both premarket and postmarket regulatory submissions for advanced vascular devices, including drug-eluting stents, catheters, and imaging systems. As a key contributor, you will work cross-functionally to ensure product compliance with FDA, PMA, and international regulatory standards, while playing a pivotal role in driving global market access.
Key Responsibilities
Provide regulatory input throughout the product lifecycle from planning through post-launch.
Develop and update regulatory strategies for U.S. and international markets.
Prepare, review, and submit regulatory documentation (e.g., PMA, IDE).
Collaborate with R&D, QA, and clinical teams to assess data and ensure readiness for submissions.
Interface with regulatory authorities to facilitate approvals and resolve issues.
Monitor applications under review and assess regulatory changes.
Support labeling compliance, product change assessments, and post-market surveillance.
Review external communications and contracts for regulatory alignment.
Maintain registrations and ensure timely submission of reports.
Contribute to risk-benefit analysis and trade compliance evaluations.
Required Skills and Qualifications
Bachelor’s degree in a related scientific or technical discipline (engineering, life sciences, or equivalent).
3–4 years of experience in a regulated industry (medical devices, nutritionals, or pharma).
2–3 years of direct regulatory affairs experience preferred; may also consider QA, R&D, or scientific experience.
Strong understanding of U.S. and international regulatory environments, including PMA and IDE submissions.
Excellent written and verbal communication skills.
Ability to assess and interpret scientific and technical data.
Strong attention to detail, organizational skills, and ability to manage multiple priorities.
Preferred Qualifications
Master’s degree in a scientific or engineering discipline.
Prior experience in the medical device industry, especially vascular technologies.
Experience with clinical study strategy (IDE), post-market clinical activities, and international registrations.
Regulatory Affairs Certification (RAC) is a plus.
Ability to lead cross-functional collaboration and deliver results under deadlines.
Perks and Benefits
Competitive base salary: $86,700 to $173,300 depending on location
Free employee medical coverage under HIP PPO Plan
Employer contribution to 401(k) retirement plan
Tuition reimbursement and student loan assistance
Degree completion through FreeU benefit
Global career growth opportunities with a Fortune 500 company
Recognized among the Best Companies to Work For globally
Company Description
Abbott is a global healthcare company focused on improving health through life-changing technologies. Its Vascular Division delivers minimally invasive treatments for patients with vascular diseases, including breakthrough stents and interventional tools. Headquartered in Santa Clara, the division supports healthcare providers worldwide.
Work Mode
On-site – Santa Clara, California
Call to Action
If you are passionate about regulatory strategy and want to make a global impact in the medical device space, apply now to join Abbott’s Vascular Division as a Senior Regulatory Affairs Specialist.
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