Labeling Engineer - II

About the role

Under supervision, the Labeling Engineer II plans, manages, and directs the creation and revision of product literature and labeling for medical devices. The role works closely with cross‑functional project teams to ensure all labeling deliverables meet regulatory standards and are delivered on schedule.

Key responsibilities

• Participate in planning, execution, and finalization of labeling projects, adhering to strict deadlines and budgets.
• Act as liaison with project stakeholders, communicating labeling expectations clearly and promptly.
• Coordinate all product labeling deliverables, including labels, IFUs, carton and pouch artwork.
• Lead cross‑functional teams through content development, managing drafts, collecting input, tracking revisions, and maintaining schedules.
• Apply labeling procedures, regulatory requirements, and quality‑system standards to ensure compliance and error‑free deliverables.
• Generate and review labeling documentation such as specifications and peer‑review reports.
• Perform Change Notice activities for review, approval, and release of labeling components.

Required profile

• Basic knowledge of labeling and product literature concepts, including labeling components, creation/review processes, standards/regulations, and eLabeling.
• Ability to follow existing procedures, research data, compile and analyze information, and make evidence‑based judgments.
• Familiarity with project‑management strategies and principles.
• Strong organizational, execution, and communication skills.
• Works under guidance from senior labeling or management staff.

Required skills

• Labeling procedures
• eLabeling
• Project management