Report this job

---

What is the problem? *

Incorrect company
Incorrect location
Job is expired
Job may be a scam
Other

OVERVIEW:

• A successful applicant for the Labeling Documentation Specialist position must possess documentation skills using MicroSoft Word and Adobe software and must have excellent written and verbal communication skills. He/she must be organized and extremely detail-oriented and able to facilitate the approval of Accurate and Compliant product labeling.
• The Labeling Documentation Specialist works in the Research and Development Department and facilitates and tracks the approval of labeling artwork for finished medical devices. This position includes the above general functions, as well as other duties in support of the approval of labeling in an Electronic Documentation Management System (EDMS).

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Responsible for the labeling work stream for revisions to medical device product labeling.
• Accurately communicate the labeling process and prepare timelines for the labeling process.
• Prepare Labeling Files/Folders containing labels to be revised or created, including supporting documentation for review.
• Redlining and editing documents using MS Word and Adobe Acrobat.
• Work in a team environment.
• Clearly communicate and work with representatives from cross-functional teams including representatives from Regulatory Affairs, Quality, R&D and Marketing to obtain the "words and phrases" and preliminary label design layout via appropriate software for product labeling.
• Track and monitor the approval of labeling.
• Track and monitor rework.
• Route label copy for review and approval electronically.
• Clearly communicate and transmit label copy information to graphic artists/label designers.
• Proofread to ensure accurate implementation of redlines.
• Knowledge of ISO standards for Medical Device Labeling and Logo standard, as well as making judgments about labeling issues based upon general knowledge of FDA Device labeling requirements.
• Upon creation or receipt of artwork or proofs, proofread them and circulate for sign off and approval and maintain artwork/proof files, including artwork tracking and retrieval.
• Able to work in an Electronic Documentation Management System to release documents to manufacturing for specification development.
• Assist personnel with locating specifications, project documentation, drawings, etc.
• Creation of Change Requests for labels using the Electronic Documentation Management System and change control software.
• Work in a highly regulated environment.

QUALIFICATIONS:

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
• High Level knowledge in the use of a personal computer with high level keyboarding skills with proficiency in Microsoft Word, Excel, PowerPoint and Acrobat Adobe Pro.

EDUCATION and/or EXPERIENCE

• 2-year Associates Degree or higher
• Ten or more years of job-related experience working as an Administrative Assistance with teams, making changes to documents using MicroSoft Word, Excel, PowerPoint and Adobe Pro.
• Knowledge of medical products preferred or experience in a regulated field.
• Familiarity with technical wording and documentation.

LANGUAGE SKILLS:

• Excellent oral and written communication skills in English are required, with abilities in Spanish a desirable additional skill.

MATHEMATICAL SKILLS:

• Basic mathematical abilities of addition, subtraction, multiplication and division are required. Some ability to apply basic concepts of basic algebra and geometry are desirable.

REASONING ABILITY:

• Ability to apply common sense understanding to carry out instructions furnished in oral, written, or diagram form. Ability to solve practical job-related problems, or recognize the need to ask supervision for assistance

PHYSICAL DEMANDS:

• Required to sit, talk, hear, stand, bend, reach with hands, lift or move up to 25 lbs. (archive record boxes). Vision requirements include ability to see and interact with a computer.

WORK ENVIRONMENT:

• This position works in a normal office environment. The noise level in the work environment is quiet to moderate. Ability to work remotely and independently with direction.