Role Overview :
Develops and coordinates product labels and package graphics requirements for cross franchise (i.e Sports Med, ENT, Robotics and Othopaedics).
Maintains the web-based product labeling database within the Prisym Medica system. Assists in developing and maintaining policies and procedures for the creation, review, and approval of all product labeling data and the definition of packaging graphics requirements.
Reports to the Manager, Global Labeling.
Responsibilities : (Please specify % amount against each responsibility)
Defines product labeling and package graphics requirements for new products and changes to existing products and reviews all labeling specifications for content and accuracy.
Works under general supervision with some opportunity for individual action.
Assists in evaluating labeling systems or software to determine the impact of implementation to the business; may recommend upgrades or enhancements to the system.
Coordinates programming requirements for label system modifications or enhancements.
Determines system functionality requirements and works with IT and Manufacturing to resolve issues relative to system performance or data maintenance.
Coordinates data compatibility with other product data systems, e.g., Matrix and SAP.
Coordinates the development of format requirements within Prisym Medica labeling system.
Maintains translations to support global labeling requirements at both manufacturing and distribution locations.
Works closely with subsidiary manufacturing operations, as well as remote distribution locations, to define and implement appropriate labeling requirements.
Coordinates training for manufacturing personnel related to label system operation and maintenance.
Works with Regulatory to ensure that product labeling meets applicable regulatory and industry requirements, i.e., FDA, ASTM, European MDR, Japanese MHLW, etc.
Executes audits to text, format, illustration, and multi-lingual databases as required.
Maintains current documentation of labeling and package graphics guidelines for the company.
Works with Complaint Handling group to investigate labeling-related complaints; initiates corrective action as required.
Other Job Functions these are additional job duties and responsibilities, which may be assigned by the supervisor :
Maintains appropriate records regarding product labeling information, system validation, etc.
Maintains current knowledge of label printing technology and software developments.
Researches technical issues, e.g., bar code technology, to assist management in formulating product labeling strategy.
Supports improvement projects to solve problems, improve efficiency, or generate labeling-related cost savings.
Scope of Position Responsibilities
For Funds, Costs or Profits :
Assists in preparing capital expenditure requests and written justification for assigned projects. Initiates purchase requisitions for labeling supplies and / or equipment.
For Supervision :
May assist or offer guidance to product data technicians and production packaging personnel. Occasionally oversees some duties of data technicians within the group.
For Internal and External Relationships :
Routine contact required with other S&N departments. Primarily interacts with Marketing, Product Development, Manufacturing, Quality, Distribution, Information Systems, Regulatory and Customer Service.
Occasional contact also required with vendors, customers, company sales personnel, and other company divisions / operations.
May interact with key surgeons and / or nursing personnel in the development of product labeling requirements.
Limits of Authority :
All decisions and recommendations are subject to review by the department Manager / Director.
For Organizational Influence :
Works directly with Marketing, Product Development, and Regulatory in establishing overall labeling requirements and related compliance issues.