Regulatory Labeling Lead (On-site)
Abbott · Princeton, NJ
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Role summary
Abbott seeks a Regulatory Labeling Lead to serve as subject matter expert for the i-STAT diagnostics product portfolio. The role involves developing labeling strategies, interpreting global regulations, establishing governance standards, and leading UDI implementation while collaborating across regulatory, quality, operations, and marketing functions. This individual contributor position is based in Princeton, New Jersey.
What they're looking for
- Bachelor's degree in Life Sciences, Clinical Laboratory Science, Engineering, Regulatory Affairs, or related field
- 8+ years of experience in Regulatory Affairs, medical device, IVD labeling, or regulated environments
- Experience interpreting global medical device and IVD labeling requirements
- Experience leading cross-functional initiatives in matrixed organizations
- Strong communication, collaboration, and stakeholder management abilities
- Demonstrated ability to influence decisions without direct authority
What you'll be doing
- Develop and maintain regulatory labeling strategies for i-STAT IVD products throughout product lifecycle
- Interpret global labeling regulations and translate requirements into compliant labeling solutions
- Establish labeling standards, procedures, and best practices to ensure consistency and compliance
- Lead global UDI strategy, implementation, and ongoing compliance activities
- Serve as subject matter expert and mentor colleagues on regulatory labeling matters
Privacy & handoff
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