Sr. Labeling Specialist II

Job Summary

The Senior Labeling Specialist II position is responsible for the strategic development, maintenance, and continuous improvement of all labeling and artwork applied to product packaging, including product labels (direct print or applied labels), Instructions for Use (IFUs), and patient-facing materials. This position provides subject matter expertise in labeling requirements across U.S. and international markets and ensures compliance with FDA, Terumo, and global regulatory standards.

The Senior Labeling Specialist II functions as an expert-level role, serving as a labeling leader within cross-functional project teams, providing guidance to less experienced staff, and driving labeling strategy for complex programs. The individual is expected to proactively identify risks, implement improvements to labeling processes, and influence organizational practices related to labeling compliance and efficiency.

This position does not include preparation of Marketing promotional materials.

Job Details/Responsibilities

• Ensure full compliance with U.S. Food and Drug Administration (FDA) regulations, international regulatory requirements, company policies, operating procedures, and quality system requirements, serving as a key authority in labeling practices.
• Act as labeling lead on complex, high-visibility projects, ensuring effective communication of ideas, information, and risks to stakeholders and senior leadership.
• Lead and influence cross-functional project teams to develop labeling strategies that ensure compliance with global regulatory requirements and optimize operational efficiency.
• Review, approve, and provide final accountability for artwork through the Terumo quality system, ensuring compliance and consistency across products and markets.
• Partner with external suppliers and internal teams to oversee complex projects involving pre-printed label stock, IFU layout, translation management, and printing needs, including authorship and approval of Material Specifications (MSS).
• Identify, lead, and implement continuous improvement initiatives in labeling processes, systems, and technology to enhance compliance and efficiency.
• Serve as primary Subject Matter Expert (SME) for labeling systems and processes, including oversight of vendor partnerships, system upgrades, validations, and resolution of escalated technical issues.

Knowledge, Skills and Abilities (KSA)

The Senior Labeling Specialist II shall demonstrate expert-level knowledge and consistent application of the following KSAs, with the ability to coach, mentor, and influence others in these areas:

1. Advanced organizational skills with exemplary attention to detail, capable of managing labeling deliverables across multiple programs simultaneously.

2. Strong leadership, collaboration, and communication skills, with the ability to influence at all organizational levels.

3. Demonstrated ability to independently lead complex labeling projects, balancing regulatory compliance, business needs, and timelines.

4. Expert application of Design Control principles and regulatory requirements in labeling-related project work.

5. Advanced analytical and problem-solving skills to lead Root Cause Analysis, support CAPA investigations, and implement sustainable solutions.

6. Proven ability to drive process improvements, standardization, and efficiency in labeling operations.

7. Ability to mentor junior team members and build organizational labeling expertise.

Qualifications/ Background Experiences

• Advanced Intermediate level position; 10+ years of relevant experience.
• Associate’s Degree, 4 year degree preferred or other relevant discipline or equivalent experience