Regulatory Affairs Manager

Abbott seeks a Regulatory Affairs Manager for its Diagnostics Division in Lake Forest, Illinois. The role involves reviewing promotional materials and providing regulatory guidance for medical devices, diagnostics, and digital health products across U.S. and global markets to ensure compliance and support business objectives.

Responsibilities

• Review and approve promotional materials for compliance with regulations and approved labeling
• Provide regulatory guidance on product claims and assess associated business risks
• Support multi-country regulatory strategies for communications across product lifecycle
• Interpret regulatory requirements and company policies to support compliant business activities
• Partner cross-functionally with stakeholders and regional affiliates on advertising and promotional communications

Requirements

• Bachelor's degree or equivalent
• 4-5 years experience in regulated industry such as medical products
• Science, engineering, or medical background preferred
• 2+ years advertising/promotions regulatory experience with IVDs or clinical chemistry products
• Knowledge of applicable regulations, labeling requirements, and corporate policies
• Regulatory Affairs Certification (RAC) is a plus

Compensation: $99,300–$198,700 base