Posted 12 months ago

Scientific & Clinical Job Details

Labeling Specialist (Medical Device)

Job Code: #883
Job Type: Contract
Salary: $35.00 - $40.00/hour
Job Location: Lake Zurich, IL

Job Description

Job Title:  Labeling Specialist

Pay:  $35.00 - $40.00/hour

Job Overview:  Responsible for developing and implementing labels in support of new product development, product support, product registrations, quality-related labeling issues, business initiatives, and compliance activities.  Coordinates with various functions on content development, global regulatory requirements, and operational tasks related to the design, development, implementation, review, and approval of all labeling for medical devices, drug products, software, and lab equipment manufactured by Company facilities and associated contract manufacturers. Collaborates with Regulatory Affairs to assess impact of new and revised label regulations and generates gap assessments and develops remediation plans.  
  • Works closely with Engineering, Regulatory, Marketing, Quality, Supply Chain, and Manufacturing teams to develop/revise product labeling content and specifications for: label dimensions, bar code requirements, language translations, country-specific information, type style, font size, clarity and conformity of wording and symbols, and formatting.
  • Leads labeling activities in support of cross-functional projects, e.g. new product launches, distributor address changes, new market expansion, etc.
  • Owns Design Change Control packages and leads projects to approve changes to product labeling.
  • Provides support to R&D engineers for implementation of labeling for new product development or changes resulting from product/process related changes.
  • Participates in labeling conferences, working groups, and other industry forums to develop and maintain
  • knowledge of new and upcoming changes to label regulations and standards. Performs gap assessments for changes in regulations and standards and develops remediation plans to maintain compliance with global label regulations.
  • Recommends and uses various labeling software and documentation management systems such as SmartSolve, BarTender, GSI Data Hub, etc.
  • lnitiates and owns Change Orders for updates to label copy and related specifications for medical devices
    and drug products using an electronic document management system (e.9. SmartSolve)
  • Coordinates implementation of label changes with manufacturing plants. Manages inventory depletion with
    plant buyers to minimize labels discards.
Requirements:
  • 3 - 5 years of labeling experience, preferably in medical device.
  • Knowledge of FDA, MDD, and other global standards and regulations for product labeling and bar coding (UDl, EU MDR, GS1, ISBT-128, HIBC-128, etc.).
  • Knowledge of GDP, GLP, GMP, and regulated Quality Systems.
  • Ability to lead and implement cross-functional projects, develop project schedules, and communicate project status.
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Project, Visio).
  • Strong interpersonal skills, including effective verbal and written communication.
  • Ability to interact effectively with functions of a global organization to achieve goals.
  • Strong critical thinking skills. o Knowledge of design change control, document control, design verification and validation, regulatory approval methods, and overall medical device industry knowledge.
  • Experience with development and implementation of labeling for a FDA regulated global medical device manufacturer or distributor preferred.