Regulatory Labeling Lead (On-site)

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

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.

• An excellent retirement savings plan with a high employer contribution.

• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.

• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Princeton, NJ location in the Abbott Point of Care (APOC), Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.

Regulatory Labeling Lead will serve as the subject matter expert for regulatory labeling strategy across the i-STAT global IVD product portfolio. You will provide strategic guidance on labeling content, regulatory interpretation, and governance while partnering with Regulatory Affairs, Quality, Operations, R&D, Marketing, and global stakeholders to ensure product labeling remains compliant, consistent, and effective throughout the product lifecycle. This is a highly visible individual contributor role that combines regulatory expertise, cross-functional leadership, and strategic influence. You will lead initiatives that shape labeling processes and standards while supporting global regulatory compliance, UDI implementation, and labeling innovation.

What You’ll Work On

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.

Labeling Governance & Compliance

• 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.

UDI & Global Initiatives

• 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.

Cross-Functional Leadership

• 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.

Required Qualifications

• 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.

Preferred Qualifications

• 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.

The base pay for this position is

$99,300.00 – $198,700.00

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Regulatory Operations

DIVISION:

APOC Point of Care

LOCATION:

United States > Princeton : 400 College Road East

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 5 % of the Time

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

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