Associate Director Regulatory Affairs – On-site (San Diego, CA)
Job Summary
Abbott’s Infectious Diseases Division is hiring an Associate Director of Regulatory Affairs to lead regulatory strategies for new product introductions (NPI) from its San Diego, CA location. This role offers the opportunity to shape regulatory direction for cutting-edge diagnostic products used worldwide and ensure global compliance with FDA, CE-IVDR, PMDA, and other regulatory bodies. Ideal for seasoned regulatory experts, this position impacts global product development and corporate strategy.
Key Responsibilities
Develop and approve new regulatory policies, SOPs, and processes.
Evaluate and advise on regulatory risks related to corporate policies and acquisitions.
Strategize and guide global product development and lifecycle management.
Analyze regulatory outcomes to refine future strategies.
Conduct due diligence for potential mergers and acquisitions.
Monitor global regulatory changes and assess their impact on product strategy.
Engage with global regulatory agencies, including FDA, CE-IVDR, and PMDA.
Lead premarket filing strategy and manage regulatory submissions.
Provide guidance on cybersecurity, EMC, and software regulatory requirements for IVD devices.
Mentor and develop regulatory affairs professionals within the organization.
Required Skills & Qualifications
Bachelor's degree in Science, Engineering, Math, or Medical fields (Master's or MBA preferred).
7+ years of regulatory affairs or related experience in a regulated industry.
Deep understanding of IVD instruments and software regulations.
Proven knowledge of FDA, IVDR, PMDA, and global regulatory processes.
Familiarity with GxPs (GCP, GLP, GMP) and regulatory laws, guidelines, and precedents.
Strong ability to analyze complex regulatory scenarios and advise management.
Exceptional leadership, communication, and problem-solving skills.
Ph.D. or RAC certification preferred.
Perks & Benefits
Salary Range: $146,700 – $293,300 annually.
Free medical coverage via HIP PPO (based on eligibility).
Outstanding 401(k) retirement plan with high employer contribution.
Tuition reimbursement & Freedom 2 Save student debt program.
FreeU education benefit for affordable degree attainment.
Career growth in an internationally acclaimed healthcare company.
Company Description
Abbott is a global leader in healthcare technology, delivering innovative diagnostics, medical devices, nutrition products, and branded pharmaceuticals to over 160 countries. The company focuses on transforming lives by empowering health management solutions across all life stages.
Work Mode
On-site – San Diego, California, United States
Call to Action
If you are a regulatory expert looking to lead global initiatives in diagnostics product development, apply now to join Abbott’s world-class team and make an impact on global healthcare innovation.
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