Global Regulatory Labeling Lead

Abbott (abbottcareers2 board); New Jersey; On-site; USD 130,000 - 190,000; Full time

Job summary

Abbott in Princeton, NJ seeks a Regulatory Labeling Lead to guide labeling strategy across the i-STAT portfolio, ensuring compliant, clear and reliable information for global markets.

You will partner with Regulatory Affairs, Quality, Operations, R&D, Marketing and other functions to shape content, governance, and processes while advancing UDI initiatives.

This high-visibility role combines regulatory expertise with leadership to influence decisions and drive labeling improvements.

Qualifications

• Bachelor's degree or equivalent in Life Sciences or regulatory field.
• 8+ years experience in Regulatory Affairs or IVD labeling.
• Experience interpreting global labeling requirements.
• Ability to lead cross-functional initiatives.
• Strong communication and stakeholder management.

Responsibilities

• Develop and maintain regulatory labeling strategies for i-STAT IVD products across the lifecycle.
• Interpret global labeling regulations and translate into compliant labeling.
• Provide strategic guidance on labeling content, warnings, instructions and use language.
• Lead labeling governance, standards, and best practices.
• Support UDI implementation and global labeling initiatives.
• Collaborate with Regulatory Affairs, Quality, Operations, R&D, Marketing and stakeholders.
• Mentor colleagues and strengthen labeling capabilities.

Skills

Regulatory labeling

Cross-functional leadership

UDI knowledge

Global regulatory compliance

Regulatory strategy

Education

Bachelor's degree in Life Sciences

Job description

Abbott in Princeton, NJ seeks a Regulatory Labeling Lead to guide labeling strategy across the i-STAT portfolio, ensuring compliant, clear and reliable information for global markets.

You will partner with Regulatory Affairs, Quality, Operations, R&D, Marketing and other functions to shape content, governance, and processes while advancing UDI initiatives.

This high-visibility role combines regulatory expertise with leadership to influence decisions and drive labeling improvements.