Senior Regulatory Affairs Specialist – Transfusion (On-site, Lake Bluff, IL)
Job Summary
Abbott is seeking a Senior Specialist – Regulatory Affairs to join its Transfusion Medicine Regulatory Team at Lake Bluff, Illinois. In this role, you will lead global regulatory submissions, ensure post-market compliance, and collaborate with cross-functional teams to maintain product registrations for transfusion medicine assays. This position is key to driving the regulatory strategy for product lifecycle management and regulatory risk assessment in a fast-paced, regulated environment.
Key Responsibilities
Serve as the regulatory product team member for transfusion medicine products.
Support regulatory activities for product market entry, launch, and on-market maintenance.
Prepare, review, and submit domestic and international regulatory submissions.
Collaborate with cross-functional teams to ensure protocol and regulatory alignment.
Provide input into product lifecycle planning and risk-benefit analysis for compliance.
Stay updated on changing global regulations impacting submission strategies.
Maintain annual licenses, listings, registrations, and post-marketing requirements.
Review promotional materials and labeling for regulatory compliance.
Assess and process change controls and cumulative product changes for submission needs.
Support product recalls and regulatory communications related to safety events.
Contribute to crisis management and issue resolution programs for regulatory matters.
Required Skills & Qualifications
Bachelor's degree in a relevant field or equivalent education and experience.
3-4 years of experience in a regulated industry (medical devices, nutraceuticals).
Knowledge of regulatory frameworks: FDA, IVDR Class D, CBER submissions (BLA, PAS), GMP, GLP, GCP.
Familiarity with submission types, registration processes, and agency structures.
Understanding of regulatory standards for product promotion, labeling, and advertising.
Strong organizational, analytical, and communication skills.
Ability to interpret and apply evolving global regulations in a dynamic environment.
Preferred Qualifications
Master’s degree in Regulatory Affairs (preferred in lieu of direct experience).
2-3 years direct regulatory affairs experience (quality assurance, R&D considered).
RAC certification from the Regulatory Affairs Professionals Society (a plus).
Perks & Benefits
Salary Range: $75,300 – $150,700 annually.
Free medical coverage under the Health Investment Plan (HIP) PPO.
Excellent employer-contributed retirement savings plan.
Tuition reimbursement, Freedom 2 Save student loan program, and FreeU education benefit.
Global career growth in a Fortune-ranked healthcare leader.
Company Description
Abbott is a world-renowned healthcare company dedicated to improving health through diagnostics, medical devices, nutrition, and branded pharmaceuticals. Its Transfusion Medicine division advances safe and innovative blood and plasma product technologies.
Work Mode
On-site – Lake Bluff, Illinois, United States
Call to Action
Ready to shape the future of transfusion medicine regulatory affairs? Apply now and be a part of Abbott’s world-class regulatory team driving innovation in healthcare.
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