Regulatory Labeling Specialist

Regulatory Labeling Specialist

Requirements

• Bachelor’s degree, in scientific or engineering field preferred
• Three (3)-plus years work experience in medical device field
• Excellent written communication skills, especially with technical information.
• Fluent in graphic design software and/or desktop publishing software
• Precise, thorough and analytical
• Proactive and adaptable to a fast-paced work environment, including managing multiple projects simultaneously

Responsibilities

• Design graphic content for label artwork using design software, such as Adobe Illustrator, as well as dedicated labeling software, such as Bartender
• Draft written content for product inserts, using desktop publishing software such as Adobe InDesign
• Apply style guidelines and branding standards to new and modified product labeling
• Verify that labeling complies with all applicable requirements
• Create and revise label items within the company’s document control system, by drafting and releasing engineering change orders
• Contribute to Labeling department process improvement initiatives
• Represent the Labeling department on project teams by collecting potential labeling inputs from other departments; interpreting the impact that projects, such as design changes, will have on labeling content; and implementing necessary modifications to the product labeling.

Preferred Qualifications

• Advanced degree or credential in regulatory affairs preferred
• Experience with e-labeling applications and/or content management system applications preferred.