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. Youll 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 bachelors 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. Were 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 Abbotts 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 Youll 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

• Bachelors 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.

Learn more about our health and wellness benefits which provide the security to help you and your family live full lives: your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer committed to employee diversity.

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The base pay for this position is

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

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