Summary:

Medical Device Labeling Specialist responsible for developing, revising, and releasing compliant product labeling, specifications, drawings, and artwork within regulated manufacturing environments. Job Requirements Bachelor's degree. Minimum 2 years of relevant experience. Experience in a regulated industry, preferably medical devices. Experience with medical product or medical package labeling. Experience with Adobe Illustrator. Experience releasing specifications and drawings through PLM systems. Experience with PLM platforms such as Windchill, Enovia, or Agile. Knowledge of medical device labeling requirements and content. Experience developing labeling artwork and releasing labeling to manufacturing. Experience with documentation and labeling design activities. Experience reviewing labeling for medical, legal, and regulatory compliance. Preferred Skills Adobe InDesign experience. BarTender software experience. Experience with labeling remediation projects. Experience with medical device product lifecycle documentation. Experience monitoring U.S. and international labeling regulations. Experience with labeling workflow or content management systems. Job Responsibilities Create, revise, review, and reproduce text and artwork used for medical product labeling. Develop labeling designs, content, images, specifications, and related documentation. Release approved labeling artwork and specifications to manufacturing. Review labeling, artwork, film, and plate proofs for compliance with applicable medical, legal, and regulatory requirements. Process labeling specifications and drawings through PLM systems. Support labeling remediation activities for existing products. Maintain labeling documentation and revision control. Monitor changes to U.S. and international labeling regulations. Review promotional and commercial materials for consistency with approved product data and labeling. Evaluate labeling processes, systems, tools, and policies. Recommend improvements to labeling processes and quality controls. Support manufacturing with approved labeling documentation and artwork.

Pay Details:

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: The California Fair Chance Act Los Angeles City Fair Chance Ordinance Los Angeles County Fair Chance Ordinance for

Employers San Francisco Fair Chance Ordinance Massachusetts Candidates Only:

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.