Product Labeling Specialist - MDR
Memphis, TN 
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Job Description

SUMMARY:

Develops and coordinates product labeling and package graphics requirements for the MDR program within assigned product lines within the Advanced Surgical Devices Division (ASD). 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 Program Manager, Labeling Operations.

ESSENTIAL JOB FUNCTIONS:

  • 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

  • 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 ORGANIZATION INFLUENCE:

  • Works directly with Marketing, Product Development, and Regulatory in establishing overall labeling requirements and related compliance issues.

QUALIFICATION REQUIREMENTS:

  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
  • The requirements listed below are representative of the knowledge, skill, and/or ability required.
  • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE:

  • Bachelor's degree in Engineering, Computer Science, Graphic Design, or related technical area plus two years of relevant experience; or Associates degree with four years of relevant experience.
  • Must possess strong organization, team leadership, communication, and interpersonal skills.

COMPUTER SKILLS:

  • Must have prior exposure to product definition data and PC software applications.
  • Experience with graphics software, and MS Access or SQL preferred.

LANGUAGE SKILLS:

  • Must have ability to read and interpret general product description information and technical procedures.
  • Ability to write reports, business correspondence, and procedures manuals.
  • Ability to present information and effectively interact with others at all levels of the organization in establishing labeling requirements.

PHYSCIAL DEMANDS:

  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
  • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Requires ability to sit for extended periods at desk, PC terminal, and at meetings approximately 70%.
  • Requires standing during presentations, manufacturing floor, etc., approximately 10%

  • Requires travel by commercial airline, automobile, or other commercial transportation approximately 5%.
  • Requires unassisted movement to different departments, meeting conference rooms, manufacturing floor, and distribution warehouse approximately 10%.
  • Mental pressure during presentations, meetings and discussions with management approximately 5%.
  • Manual Dexterity: Requires use of hands and arms to operate computer, printer, general office equipment, production labeling equipment, and to record written information.
  • Requires ability to concentrate on detailed assignments for extended periods and use creative skills in the design of product labeling.
  • Audible/Visual Demands: Visual performance is essential for use of PC, presentations, travel, and to move about in a manufacturing environment without endangering personal safety or the safety of others.
  • Close vision for use of PC and for review of detailed documents required for extended periods. Test for visual acuity and color blindness.
  • Requires the ability to hear and verbally communicate during telephone conversations, discussions during meetings, communication assignments; and to communicate with peers and associates and avoid dangerous situations while in the manufacturing area.

WORK ENVIRONMENT:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.

Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.

Veterans are strongly encouraged to apply.


Smith & Nephew is an Equal Opportunity/Affirmative Action Employer -EEO/AA/Minorities/Females/Disabled/Veterans and participates in the E-Verify Program.

As an equal opportunity/affirmative action employer, Smith & Nephew is committed to a diverse workforce. If you are a qualified individual in the US with a disability or a disabled veteran, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access Smith & Nephew's career website as a result of your disability. You can request reasonable accommodations by calling Recruitment Support at 1-901-399-6192.

 

Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Associate Degree
Required Experience
2+ years
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