JOB DESCRIPTION:The OpportunityThis 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.
The
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 OnRegulatory 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.
Apply NowLearn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://abbottbenefits.com/
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)
