Labeling Engineer II: Regulatory & Packaging Specialist

Integer; United States; Remote; USD 70,000 - 102,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Disability insurance

Life insurance

Adoption benefits

401(k) with company matching

Paid time off and holidays

Job summary

Integer is seeking a labeling specialist to manage the labeling process across product development, ensuring accuracy of Instructions for Use and consistent presentation throughout the product life cycle. You will collaborate with cross-functional teams, perform UDI database updates (FDA GUDID/EUDAMED), and support packaging and labeling validation plans.

A Bachelor’s degree or 3+ years of GMP/FDA/Change Control experience is required; proficiency with Microsoft Office, Adobe InDesign and

Qualifications

• Bachelor’s degree in a related field or 3+ years of GMP/FDA/Change Control experience.
• Strong written and oral communication skills and attention to detail.
• Ability to work in a team environment and manage multiple tasks.

Responsibilities

• Adheres to labeling requirements and regulatory standards across product lifecycle.
• Prepares and controls labels and Instructions for Use with change control.
• Performs UDI database updates and supports packaging/label validation plans.

Skills

Written and verbal communication

Attention to detail

Organization & time management

Teamwork

Regulatory labeling knowledge

Education

Bachelor’s degree or related field

3+ years GMP/FDA/Change Control experience

Tools

Microsoft Office

Adobe InDesign

Adobe Illustrator

Label creation software

Job description

Integer is seeking a labeling specialist to manage the labeling process across product development, ensuring accuracy of Instructions for Use and consistent presentation throughout the product life cycle. You will collaborate with cross-functional teams, perform UDI database updates (FDA GUDID/EUDAMED), and support packaging and labeling validation plans.

A Bachelor’s degree or 3+ years of GMP/FDA/Change Control experience is required; proficiency with Microsoft Office, Adobe InDesign and