23d ago

Regulatory Labeling Lead (On-site)

United States - New Jersey - Princetonlead

Legal & ComplianceRegulatory

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Quick Summary

Overview

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare,

Technical Tools

Legal & ComplianceRegulatory

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

What We Offer

~1 min read

Regulatory Labeling Strategy

✓Develop and maintain regulatory labeling strategies for i-STAT IVD products throughout the product lifecycle.

✓Interpret global labeling regulations and standards and translate requirements into practical, compliant labeling solutions.

✓Provide strategic guidance on labeling content, claims, warnings, precautions, symbols, instructions, and intended use language.

✓Evaluate complex and ambiguous labeling challenges and recommend risk-based approaches.

✓Establish and maintain labeling standards, procedures, and best practices.

✓Drive consistency across labels, instructions for use, user documentation, packaging, and related product information.

✓Ensure labeling decisions are appropriately documented and inspection ready.

✓Support continuous improvement of labeling processes and controls.

✓Lead global UDI strategy, implementation, and ongoing compliance activities.

✓Support initiatives involving digital labeling, global harmonization, and labeling process transformation.

✓Monitor evolving global labeling requirements and assess impact to business processes and products.

✓Serve as recognized expert on regulatory labeling matters.

✓Lead cross-functional discussions to align stakeholders on labeling strategies and content decisions.

✓Influence decisions through technical expertise and regulatory knowledge.

✓Mentor colleagues and help strengthen organizational labeling capabilities.

Requirements

~1 min read

Bachelor's degree in Life Sciences, Clinical Laboratory Science, Engineering, Regulatory Affairs, Technical Communications, or a related field, or an equivalent combination of education and experience.
Typically, 8+ years of experience in Regulatory Affairs, medical device or IVD labeling, quality systems, product development, or other regulated environments.
Experience interpreting global medical device and/or IVD labeling requirements.
Experience leading cross-functional initiatives in a matrixed organization.
Strong communication, collaboration, and stakeholder management skills.
Demonstrated ability to influence decisions without direct authority.

Experience supporting global IVD products and international regulatory requirements.
Experience with UDI compliance, implementation, and lifecycle management.
Experience supporting regulatory inspections, audits, or external assessments.
Experience developing global labeling strategies and governance processes.
RAC, ASQ, or other relevant regulatory or quality certifications.
Experience with digital labeling, IVDR, MDR, or global labeling harmonization initiatives.

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Regulatory Operations

APOC Point of Care

United States > Princeton : 400 College Road East

Standard

Yes, 5 % of the Time

Not Applicable

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf