Regulatory Labeling Lead (On-site)
$99,300–$198,700 year
On-sitePrinceton, New Jersey, United States
Job Summary
Develop and maintain regulatory labeling strategies for i-STAT IVD products throughout the product lifecycle, interpreting global regulations to translate requirements into compliant labeling solutions. Establish labeling standards, procedures, and best practices to ensure consistency across labels, instructions for use, and user documentation while driving inspection readiness. Lead global UDI strategy, implementation, and ongoing compliance activities, including monitoring evolving requirements and assessing impacts on business processes. Serve as a recognized subject matter expert to lead cross-functional discussions with Regulatory Affairs, Quality, Operations, R&D, and Marketing to align stakeholders on labeling content and decisions. Mentor colleagues to strengthen organizational labeling capabilities and influence decisions through technical expertise without direct authority.
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
- 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
- Yes, 5 % of the Time
Desired 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
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