Regulatory Affairs Manager – Vascular (On-site, Santa Clara, CA)
Job Summary
Abbott Vascular seeks a Regulatory Affairs Manager to join its Santa Clara, CA division. This on-site role involves leading regulatory strategy, managing FDA and international submissions, and ensuring compliance throughout the product lifecycle for innovative vascular medical devices, including drug-eluting stents and imaging catheters. The ideal candidate will drive regulatory approval processes, advise cross-functional teams, and handle complex product changes to meet global market requirements.
Key Responsibilities
Provide regulatory input for product lifecycle planning and manufacturing processes.
Develop and submit robust regulatory applications (FDA, EU, and international).
Lead pre- and post-approval clinical strategies and regulatory submission activities.
Anticipate regulatory obstacles and devise solutions in collaboration with cross-functional teams.
Assess and compile development, clinical, and quality data for regulatory filings.
Negotiate and liaise with global regulatory agencies to ensure timely submission approvals.
Oversee compliance with US and international post-market approval regulations.
Evaluate clinical and manufacturing changes for regulatory impact and filing strategies.
Manage and execute scientific and technical regulatory activities independently.
Lead cross-functional or cross-divisional regulatory project teams as needed.
Required Skills & Qualifications
Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or related fields.
4+ years of experience in a regulated industry (medical devices preferred); 2-5 years in regulatory preferred.
Strong written and verbal communication skills with diverse teams and regulatory agencies.
In-depth knowledge of FDA and global regulatory guidelines and product approval requirements.
Ability to lead regulatory strategy development and scientific problem-solving.
Preferred Qualifications
Master’s or Ph.D. in a technical discipline.
RAC certification from the Regulatory Affairs Professionals Society.
Experience with PMA/IDE submissions and Class III medical devices.
Familiarity with combination product regulatory processes and IDE clinical trial strategies.
Strong organizational skills with ability to manage multiple projects simultaneously.
Perks & Benefits
Salary Range: $112,000 – $224,000 annually.
Free medical coverage via Health Investment Plan (HIP) PPO.
Exceptional retirement savings plan with generous employer contributions.
Tuition reimbursement, Freedom 2 Save student debt program, and FreeU education benefit.
Career development in a Fortune-recognized global healthcare leader.
Company Description
Abbott is a worldwide leader in healthcare technology, delivering cutting-edge solutions in diagnostics, medical devices, pharmaceuticals, and nutrition. With operations in 160+ countries, Abbott focuses on advancing quality of life through innovative products that support cardiovascular and vascular health.
Work Mode
On-site – Santa Clara, California, United States
Call to Action
Are you ready to lead regulatory excellence in medical device innovation? Apply now to become a part of Abbott’s dynamic Vascular Regulatory Affairs team and shape the future of cardiovascular healthcare solutions.
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