Job Description
Job Description:
This role focuses on developing, managing, and maintaining compliant medical device labeling using BarTender labeling software within a regulated environment. The Labeling Specialist ensures that all labels meet FDA and other regulatory requirements, supports product lifecycle activities through PLM/QMS platforms, and contributes to high-quality documentation and quality systems management. The position offers the opportunity to work on multiple projects, including supporting a 510(k) submission, while collaborating with a strong quality leadership team in a modern facility with room for professional growth.
Responsibilities:
+ Create, configure, and maintain medical device labels using BarTender labeling software, ensuring accuracy, consistency, and regulatory compliance.
+ Manage the full label lifecycle, including creation, review, approval, release, and controlled changes in alignment with quality and regulatory requirements.
+ Work...
This role focuses on developing, managing, and maintaining compliant medical device labeling using BarTender labeling software within a regulated environment. The Labeling Specialist ensures that all labels meet FDA and other regulatory requirements, supports product lifecycle activities through PLM/QMS platforms, and contributes to high-quality documentation and quality systems management. The position offers the opportunity to work on multiple projects, including supporting a 510(k) submission, while collaborating with a strong quality leadership team in a modern facility with room for professional growth.
Responsibilities:
+ Create, configure, and maintain medical device labels using BarTender labeling software, ensuring accuracy, consistency, and regulatory compliance.
+ Manage the full label lifecycle, including creation, review, approval, release, and controlled changes in alignment with quality and regulatory requirements.
+ Work...