Global Regulatory Labeling Lead - Strategy & Compliance

Abbott; Princeton (AL); On-site; USD 99,000 - 199,000; Full time

Job summary

Abbott in Princeton, NJ, is seeking a Regulatory Labeling Lead to guide labeling strategy across the entire i-STAT global IVD portfolio. You will partner with Regulatory Affairs, Quality, Operations, R&D, Marketing, and global teams to ensure compliant, consistent labeling throughout the product lifecycle.

This highly visible individual contributor role blends regulatory expertise with cross-functional influence, driving UDI, labeling standards, and process improvements across regions and

Qualifications

• Bachelor's degree or equivalent in a life sciences or regulatory field.
• 8+ years in regulatory affairs, labeling, or related regulated environments.
• Experience interpreting global medical device/IVD labeling requirements.
• Ability to lead cross-functional initiatives in a matrixed org.
• Strong communication, collaboration, and stakeholder management.
• Proven ability to influence decisions without direct authority.

Responsibilities

• Lead regulatory labeling strategy across the i-STAT global IVD portfolio.
• Provide guidance on labeling content, regulatory interpretation, and governance.
• Partner with Regulatory Affairs, Quality, Operations, R&D, Marketing, and global stakeholders.
• Drive labeling governance, standards, and continuous process improvements.

Skills

Cross-functional leadership

Stakeholder management

Communication skills

Influence without authority

Education

Bachelor's degree in Life Sciences or related field

Equivalent education/experience

Job description

Abbott in Princeton, NJ, is seeking a Regulatory Labeling Lead to guide labeling strategy across the entire i-STAT global IVD portfolio. You will partner with Regulatory Affairs, Quality, Operations, R&D, Marketing, and global teams to ensure compliant, consistent labeling throughout the product lifecycle.

This highly visible individual contributor role blends regulatory expertise with cross-functional influence, driving UDI, labeling standards, and process improvements across regions and