|Title:||Regulatory Label Coordinator|
|Job Location:||Earth City, MO|
Young Dental is a leading designer, manufacturer, and marketer of consumables, instruments, and other items used in the dental industry. The products we create begin as a bright idea either from within our organization, backed by extensive research and development, or are generated by clinical professionals worldwide. Every product we manufacture is subject to strict quality control measures before being made available to a dental office. The result is a high-quality product that provides clinical benefits to the patient while providing efficacy, reliability, and comfort to the dental professional. Young Dental is a wholly owned subsidiary of Young Innovations, Inc. with sales in excess of $140 million and covers a broad portfolio of market-leading products across a variety of dental categories.
This position will coordinate the creation/revision of printed packaging for products at the Earth City facility. This position will also support the creation/revision of barcode labeling for use at the Earth City facility.
Initiate and complete change controls and document change requests for new or revised printed packaging.
Communicate with print suppliers throughout the process including review of proofs, approving project to go forward, and creating purchase orders.
Create and revise barcode labels as needed.
Maintain database of barcode labels print specifications.
Review change controls for potential impact to any printed packaging or barcode labeling.
Assist production team with barcode label printing issues and troubleshooting.
Perform other duties as assigned.
Training and Experience
High school diploma required. Some college or Associates Degree a plus; or equivalent combination and experience.
Knowledge, Abilities and Skills
- Knowledge of labeling requirements for medical devices per CFR 801 preferred
- Knowledge of cGMP preferred
- Ability to track and manage change control and document change processes.
- Ability to interact and communicate effectively with internal departments to support the change control and document change processes.
- Ability to interact and communicate with external vendors to support printed packaging creation and revisions.
Proficient in use of Microsoft Office products including Excel, Word, and Outlook.
Manual dexterity and ability to work on a computer for extended periods of time.
Office environment and occasional exposure to manufacturing plant environment, with some abnormal variations in temperature, unavoidable fumes, noise, dust and atmospheric conditions.