Job Summary :
The Labeling Documentation Specialist is responsible for creating new entries and maintaining large database of control documents related to all aspects of medical device labeling.
Duties & Responsibilities :
Manage label documentation to accurately convey product information and ensure compliance with regulatory requirements.
Update, and maintain labeling documents ( C / O) as part of engineering packaging drawings.
Perform additional duties or special projects as assigned, contributing to continuous improvement initiatives within the labeling department.
Minimum Qualifications :
Intermediate in Excel
Familiar with Agile and CO workflows
Experience in a document control / engineering setting
Experience with documentation approval systems; (Agile)
Must be highly PC literate
Good communications skills / ability to work with multiple departments
Detail Oriented and can follow instructions
Preferred Qualifications :
Familiar with BarTender – it’s a plus, but not required
Have knowledge about EU MDR requirements – it’s a plus, but not required
Familiar with AutoCad / SolidWorks – it’s a plus, but not required
Education :
High School Diploma or GED Certificate
Certified Training in CAD Drafting AutoCad or Solidworks is a plus.
A.A. in packaging design or related field is a plus
B.S. Degree in packaging design or related field is a plus
BarTender, EU MDR, AutoCad, Solidworks
Label Document Specialist • Irvine, CA, US