Director, Regulatory Affairs | Abbott, Lake Forest, IL (On-site)
Job Summary
Abbott, a global leader in healthcare innovation, is seeking a Director of Regulatory Affairs for its Diagnostics division in Lake Forest, Illinois. This high-impact on-site leadership role focuses on shaping and executing global regulatory strategies for advanced diagnostic products. The role demands deep expertise in FDA, CDRH, CBER regulatory pathways, along with proven team leadership and cross-functional coordination skills in a regulated environment.
Key Responsibilities
Drive development and approval of global regulatory policies, SOPs, and strategic processes.
Shape and implement regulatory strategies across the entire product lifecycle.
Oversee pre-market and post-market regulatory compliance for diagnostic products.
Ensure robust crisis management, issue resolution, and product recall processes.
Lead regulatory due diligence for acquisitions and advise senior management.
Mentor, recruit, and develop a high-performing regulatory affairs team.
Provide leadership in industry forums, shaping regulatory policy and standards.
Ensure timely and effective communication with global regulatory authorities.
Manage budget, resources, and strategic planning for regulatory operations.
Ensure advertising, promotion, and public communications meet regulatory standards.
Required Skills & Qualifications
Bachelor’s degree in science, engineering, math, or related medical fields.
7–10 years’ experience in regulated industries (medical devices, diagnostics).
Significant experience in regulatory affairs, FDA interactions preferred.
In-depth understanding of global regulatory guidelines (FDA, CDRH, CBER).
Strong leadership, decision-making, and cross-functional team management skills.
Ability to forecast regulatory trends and adjust strategies accordingly.
Excellent verbal and written communication skills for stakeholder engagement.
Preferred Skills & Qualifications
Advanced degree (MS, PhD, or MBA) in technical, scientific, or regulatory discipline.
RAC certification preferred.
Background as an FDA CDRH/CBER reviewer advantageous.
Familiarity with GxPs (GCP, GLP, GMP), global labeling, and international regulatory frameworks.
Perks & Benefits
Competitive Salary Range: $147,300 – $294,700 annually.
Free medical coverage via Health Investment Plan (HIP) PPO.
Excellent 401(k) retirement plan with high employer contributions.
Tuition reimbursement and education benefits including FreeU program.
Paid vacation, holidays, and family-friendly leave policies.
Global career growth opportunities within a Fortune-recognized organization.
Company Description
Abbott is a world-renowned healthcare leader driving innovation in diagnostics, medical devices, nutrition, and branded pharmaceuticals. With 114,000+ employees worldwide, Abbott's cutting-edge diagnostics solutions help healthcare providers make faster, smarter decisions, improving patient outcomes globally.
Work Mode
On-site — Lake Forest, Illinois, United States.
Call to Action
Ready to shape the future of diagnostics through regulatory excellence? Apply now to join Abbott’s visionary team and impact healthcare worldwide.
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