Regulatory Labeling Lead (On-site)
About The Position
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. 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.
Requirements
- 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.
Nice To Haves
- 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.
Responsibilities
- 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.
Benefits
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
