Job Summary
Abbott, a global leader in healthcare, is seeking a Director of Regulatory Affairs for its Diagnostics Division based in Lake Forest, IL. This is a high-level, on-site role focused on shaping global regulatory strategies and ensuring compliance across product lifecycles. The ideal candidate brings deep regulatory knowledge, leadership expertise, and a strong track record of driving successful FDA and international submissions.
Key Responsibilities
Lead the development and execution of regulatory strategies for new and existing products globally.
Direct and manage a team of regulatory professionals and support their career development.
Serve as a liaison with FDA, EMA, and other global regulatory bodies.
Provide regulatory input across product development, clinical trials, manufacturing, and labeling.
Manage global submissions, including 510(k), PMA, and CE Mark.
Ensure compliance with international regulations (FDA, ISO, ICH, GCP, GMP).
Support regulatory due diligence for acquisitions and business development.
Represent the company in regulatory policy discussions and trade associations.
Oversee risk assessments, advertising/promotion reviews, and recall activities.
Required Qualifications
Bachelor’s degree in life sciences, engineering, or a related field; advanced degree preferred.
Minimum 7 to 10 years of regulatory experience in medical devices, diagnostics, or pharmaceuticals.
Proven experience with FDA regulations and global submission strategies.
Familiarity with CDRH, CBER, ISO, ICH, GCP, and GMP standards.
Regulatory Affairs Certification (RAC) or equivalent is advantageous.
Strong leadership, communication, and cross-functional team collaboration skills.
Compensation and Benefits
Salary range: $147,300 – $294,700
Comprehensive health coverage (including free options under HIP PPO Plan)
Retirement savings plan with high employer contribution
Student loan assistance and tuition reimbursement
Free access to online bachelor’s degree programs via FreeU
Global internal mobility and development opportunities
Wellbeing programs and inclusive work culture
About the Company
Abbott is a global healthcare company with over 114,000 employees in 160+ countries. Its Diagnostics Division delivers innovative testing solutions that improve healthcare systems worldwide. Abbott is recognized for workplace excellence and diversity and is consistently named among the best companies to work for in STEM, healthcare, and corporate social responsibility.
Work Mode
On-site – Lake Forest, Illinois, United States
Call to Action
If you’re a regulatory leader ready to make a global impact, join Abbott’s Diagnostics Division and shape the future of healthcare innovation. Apply now to be part of a world-class regulatory team.
Apply here: Visit Abbott Careers
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