Labeling Engineer II - GMP & Regulatory Solutions

Integer Holdings Corporation; United States; On-site; USD 69,750 - 102,300; Full time

Benefits offered by this job

Medical, dental, vision

401(k) with company match

Paid time off and holidays

Parental leave

Job summary

Integer Holdings Corporation seeks a labeling professional to join the Regulatory Affairs team in the United States. You will manage labeling development, update Instructions for Use, and ensure documentation complies with FDA, QMS, and Change Control requirements across product lifecycles.

You will collaborate with cross-functional teams to prepare regulatory submissions, support UDI data management in GUDID/EUDAMED, and drive improvements in labeling processes and translations while

Qualifications

• Bachelor’s degree in a related field or 3+ years of GMP, FDA, Change Control experience.
• Strong written and oral communication skills.
• Knowledge of Regulatory labeling landscape.

Responsibilities

• Adheres to labeling requirements and regulatory standards across the product lifecycle.
• Plans, coordinates, and executes labeling updates and Change Control Requests.
• Maintains labeling translations and prepares regulatory documentation.
• Supports UDI data management in FDA GUDID and EUDAMED databases.
• Collaborates with cross-functional teams on labeling development and validation plans.
• Supports regulatory submissions related to labeling changes.

Skills

Documentation

Regulatory labeling

Attention to detail

Communication

Teamwork

MS Office

Adobe InDesign

Adobe Illustrator

Label creation software

Education

Bachelor’s degree in a related field

Tools

Adobe InDesign

Adobe Illustrator

Label creation software

MS Office

Job description

Integer Holdings Corporation seeks a labeling professional to join the Regulatory Affairs team in the United States. You will manage labeling development, update Instructions for Use, and ensure documentation complies with FDA, QMS, and Change Control requirements across product lifecycles.

You will collaborate with cross-functional teams to prepare regulatory submissions, support UDI data management in GUDID/EUDAMED, and drive improvements in labeling processes and translations while