Associate Director – Regulatory Affairs (On-site)
Location: San Diego, California
Company: Abbott – Infectious Diseases Diagnostics Division
Work Mode: On-site
Employment Type: Full-Time
Salary Range: $146,700 – $293,300 (range may vary by location)
Job Summary
Abbott, a global leader in healthcare and diagnostics innovation, is hiring an Associate Director, Regulatory Affairs to join its Infectious Diseases Division in San Diego, CA. In this high-impact leadership role, you’ll oversee global regulatory strategies across product lifecycles—from premarket submissions to post-market compliance—for IVD instruments and software. Your regulatory acumen will directly contribute to delivering life-changing diagnostic technologies that empower smarter clinical decisions.
This is an ideal opportunity for experienced professionals in regulatory affairs, quality systems, or diagnostic product compliance who want to drive international regulatory approvals in a fast-evolving healthcare landscape.
Key Responsibilities
Develop and lead global regulatory strategies for new product introductions (NPI) and lifecycle management.
Interface with global regulatory bodies including FDA, PMDA, and CE-IVDR agencies.
Lead regulatory due diligence for mergers, acquisitions, and partnerships.
Approve submission strategies and monitor their progress through regulatory authorities.
Collaborate with R&D, QA, marketing, and legal teams to ensure regulatory alignment.
Track and evaluate new regulations, updating internal SOPs and strategies accordingly.
Represent Abbott in industry trade associations and regulatory policy forums.
Lead pre-approval compliance initiatives and respond to regulatory authority queries.
Mentor and develop junior regulatory professionals to ensure team expertise.
Required Skills & Qualifications
Bachelor’s degree in a science or engineering discipline (biology, chemistry, microbiology, immunology, pharmacology, etc.); Master’s or Ph.D. preferred.
Minimum 7 years in a regulated industry (regulatory, QA, R&D, or operations).
Proven experience with IVD instruments and software compliance.
Expertise in global regulatory frameworks: FDA, CE-IVDR, PMDA, cybersecurity, EMC, and software validation.
Solid understanding of GxPs, regulatory submissions, labeling laws, and advertising regulations.
Familiarity with international trade requirements and ethical regulatory standards.
RAC certification or equivalent preferred.
Perks & Benefits
Competitive base salary: $146,700 – $293,300
Free employee medical coverage via HIP PPO Plan
Excellent 401(k) retirement plan with high employer contribution
Tuition reimbursement, FreeU education, and student loan repayment programs
Career advancement in a globally recognized healthcare company
Inclusion in a workplace consistently ranked among Fortune’s Most Admired Companies
Culture of diversity, innovation, and personal well-being
Company Description
Abbott is a global healthcare technology company delivering diagnostics, medical devices, branded generics, and nutritional products to millions across 160+ countries. In its Infectious Diseases Division, Abbott is a market leader in IVD innovation, enabling laboratories and clinicians to make faster, more accurate medical decisions.
Work Mode
On-site – San Diego, California
Call to Action
Are you ready to drive global regulatory strategy and deliver transformative diagnostic solutions? Apply today to join Abbott and build a healthcare future that empowers millions worldwide.
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