Regulatory Labelling Associate

Job Title

By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.

At Integer, our values are embedded in everything we do.

Core Values

Customer

We focus on our customers' success

Innovation

We create better solutions

Collaboration

We create success together

Inclusion

We always interact with others respectfully

Candor

We are open and honest with one another

Integrity

We do the right things and do things right

Accountabilities & Responsibilities

Adheres to Integer Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements. Prepares, creates, and controls labels and Instructions for Use according to procedure, including the updates to these documents throughout the product life-cycle.

Review labeling documents to ensure that formatting of text and graphics conform to established guidelines for consistency, technical construction, and overall presentation.

Tracks and maintains labeling documents using process tools for revision control.

Prepares and manages labeling translations activities.

Review and approve vendor proofs.

Perform upload and maintain the FDA UDI GUDID database.

Initiate and/or implement Change Control Requests pertaining to labeling updates.

Follow through on open Change Control Requests and evaluate the impact assessment related to labeling updates.

Strive for continuous improvement and consistency in deliverables.

Communicates with internal and external customers regarding ongoing labeling updates.

Ensure labeling are up to date and accurate.

Collaborate with cross-functional teams to ensure labeling deliverables are on-track with each project.

Provides support with internal and external Regulatory submission package.

Provide support to labeling projects for new product development and current production.

Collaborate with cross-functional teams to review product specifications evaluating product characteristics, special-handling and safety requirements, and type of materials required for labeling development.

Support the execution of Label Validation Plans and Reports as needed.

Ensure labeling is compliant with regulatory, customer and specification requirements and standards.

Provide technical support for label printing and database management.

Performs other duties as required.

Education & Experience

Minimum Education & Experience:

A minimum of three 3 years of experience of GMP, FDA, Change Control process

General understanding of U.S. FDA UDI and EU MDR labeling requirements

Knowledge & Skills

Strong attention to detail. Experienced with Microsoft Office.

Strong organizational and time management abilities

Strong proficiency with Adobe InDesign

Proficiency with Adobe Illustrator

Knowledge of label creation software