Labeling Engineer II — Regulatory & Packaging Expert

Regulatory Jobs; United States; Remote; USD 70.000 - 102.000; Vollzeit

Benefits dieser Stelle

Medical, dental, vision

Disability and life insurance

401(k) with company match

Parental leave

Paid time off & holidays

Adoption benefits

Zusammenfassung

Integer seeks a Regulatory Labeling Specialist in the United States to plan, prepare, and control labeling for major projects, ensuring compliance with FDA, GMP and UDI requirements.

You will manage change controls, translations, and database entries, review label content, and support packaging validation. A Bachelor’s degree or 3+ years in regulated labeling is required, with strong communication and attention to detail.

Qualifikationen

• Bachelor’s degree in a related field or 3+ years of GMP/FDA/Change Control experience.
• Strong written and oral communication skills.
• Excellent attention to detail and organization.
• Experience with regulatory labeling landscape and cross-functional collaboration.
• Proficiency with labeling tools and design software.

Aufgaben

• Plans, schedules, conducts, and coordinates labeling phases for projects.
• Prepares and controls labels and Instructions for Use through product life cycle.
• Reviews labeling documents for accuracy and formatting.
• Implements Change Control Requests for labeling updates.
• Maintains UDI databases (FDA GUDID, EUDAMED).
• Supports labeling process tech improvements and translations.
• Collaborates with cross-functional teams on labeling deliverables.
• Executes packaging and labeling validation plans and reports.

Kenntnisse

Strong communication

Attention to detail

Organizational skills

Team player

Regulatory labeling

Ausbildung

Bachelor’s degree in a related field

Tools

Microsoft Office

Adobe InDesign

Adobe Illustrator

Label creation software

Jobbeschreibung

Integer seeks a Regulatory Labeling Specialist in the United States to plan, prepare, and control labeling for major projects, ensuring compliance with FDA, GMP and UDI requirements.

You will manage change controls, translations, and database entries, review label content, and support packaging validation. A Bachelor’s degree or 3+ years in regulated labeling is required, with strong communication and attention to detail.