Regulatory Affairs Manager – Abbott Vascular (On-site)
Location: Santa Clara, California
Company: Abbott
Work Mode: On-site
Job Type: Full-Time
Salary Range: $112,000 – $224,000 (location-dependent)
Job Summary
Abbott is hiring a Regulatory Affairs Manager in its Vascular division at Santa Clara, CA. This pivotal role supports global and U.S. regulatory submissions for innovative Class III medical devices and combination products. You will lead submission strategies, interface with regulatory agencies, manage complex post-market requirements, and mentor junior staff—all within a fast-paced and compliant environment. Ideal for professionals experienced in PMA/IDE submissions, clinical strategy, and global regulatory frameworks.
Key Responsibilities
Provide regulatory input throughout the product lifecycle
Prepare and manage FDA and international submissions including PMA, IDE, and combination product filings
Support pre- and post-approval clinical strategies
Analyze and interpret regulatory guidelines and implement compliance measures
Identify and resolve potential regulatory roadblocks early
Negotiate with regulatory authorities to expedite approvals
Oversee post-marketing surveillance and regulatory compliance activities
Lead cross-functional collaboration on product and clinical development strategies
Mentor junior staff and lead cross-divisional project teams when necessary
Required Skills & Qualifications
Bachelor’s degree in science, engineering, pharmacy, or a related field
Minimum 4 years’ experience in regulated industries (2–5 in regulatory preferred)
Solid understanding of FDA, EU, and international regulations
Strong communication and negotiation skills
Ability to manage regulatory strategy, submission planning, and documentation review
Prior experience with complex product changes, post-market approvals, and clinical studies
Proven ability to manage multiple priorities and regulatory timelines
Proficiency in interpreting and applying global regulatory requirements
Preferred Qualifications
Master’s or Ph.D. in a technical field
RAC certification (Regulatory Affairs Certification)
Experience with combination products and Class III medical devices
Familiarity with IDE trial strategy and post-market clinical activities
PMA and international submission experience strongly preferred
Perks & Benefits
Competitive base pay: $112,000 – $224,000
High-contribution retirement savings plan
Free HIP PPO medical plan (upon eligibility)
Tuition reimbursement and Freedom 2 Save student loan program
FreeU education program for bachelor’s degree completion
Global career advancement opportunities
Recognized as a Top Employer by Fortune and other global platforms
Company Description
Abbott is a world-renowned healthcare leader, delivering life-changing innovations across diagnostics, medical devices, nutritionals, and branded generics. With operations in 160+ countries and over 114,000 employees, Abbott is a pioneer in improving lives through technology-driven healthcare.
Work Mode
On-site – Santa Clara, California
Call to Action
Advance your regulatory career with a global healthcare leader. If you're ready to lead complex global submissions and shape medical device innovation, apply now to join Abbott's high-impact regulatory team.
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