Regulatory Affairs Manager (RA Manager) – On-site (Abbott Park, IL)
Job Summary
Join Abbott’s Quality & Regulatory (AQR) team as a Regulatory Affairs Manager (RA Manager) at Abbott Park, Illinois. This position offers a unique opportunity to lead critical regulatory projects, manage FDA site registrations, and ensure compliance with evolving global regulatory standards, including EU MDR/IVDR and UDI requirements. This on-site role is ideal for experienced professionals ready to influence regulatory strategy and cross-divisional processes in the medical device industry.
Key Responsibilities
Lead and support corporate-led regulatory programs ensuring compliance with emerging requirements.
Organize and drive project initiatives, work plans, and team meetings aligned with AQR leadership priorities.
Serve as process owner for FDA site registrations and device listing activities; maintain related process documentation.
Collaborate across business units to coordinate regulatory activities and prepare management reviews.
Identify potential risks, obstacles, and develop proactive solutions.
Prepare and deliver concise, data-driven communications to senior management and regulatory teams.
Develop and implement new regulatory policies, procedures, and documentation in alignment with global standards.
Maintain and enhance Power BI dashboards to visualize regulatory metrics and KPIs.
Ensure compliance with all corporate policies, regulatory procedures, and FDA requirements.
Foster positive relationships across departments, vendors, and external partners.
Required Skills & Qualifications
Bachelor’s Degree in Life Sciences or related discipline.
5+ years of project management experience in a regulated industry.
In-depth knowledge of medical device regulations, including device classification and risk management.
Expertise in Power BI and data visualization tools.
Familiarity with EU MDR/IVDR, UDI, and FDA FURLS systems.
Strong cross-functional leadership and team coordination abilities.
Professional certifications like PMP or RAC are a plus.
Perks & Benefits
Salary Range: $97,300 – $194,700 annually.
Free medical coverage under HIP PPO plan (subject to eligibility).
Generous employer contribution towards 401(k) retirement savings.
Tuition reimbursement and student loan assistance via Freedom 2 Save program.
FreeU education benefit for affordable bachelor’s degree completion.
Career development opportunities with a global healthcare leader.
Company Description
Abbott is a global leader in healthcare technology, providing innovative solutions across diagnostics, medical devices, nutrition, and pharmaceuticals. With a presence in over 160 countries, Abbott empowers people to lead healthier lives through groundbreaking science and trusted healthcare products.
Work Mode
On-site – Abbott Park, Illinois, United States
Call to Action
Ready to advance your regulatory affairs career with a global healthcare pioneer? Apply now to become a vital part of Abbott’s world-class Regulatory Affairs team and make a lasting impact on patient safety and healthcare innovation.
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