Job Description:

Description

Come Join our Team!

Henry Schein Orthodontics, a subsidiary of Henry Schein Inc, is a leading manufacturer of orthodontic appliances, clear aligners, and technology for the global orthodontic marketplace. We provide innovative products, services, and solutions to help orthodontic practitioners deliver exceptional care to their patients, while concurrently building successful practices. In the USA, our products are marketed to orthodontic practitioners through a strong direct sales force, and internationally, our products are sold in more than 85 countries through 160+ distributors. We are dedicated to providing the orthodontic profession with high quality, innovative products and treatment solutions, backed by attentive customer service and educational support. At Henry Schein Orthodontics everyone is part of the team, with the same goal; to improve patient care and continue to "Advance the Future of Orthodontics" for generations to come.

This position is responsible for leading medical device labeling projects, including, but not limited to product labels, IFUs, translations, labeling software systems and UDI initiatives, as necessary, to market Ortho Organizers' and Henry Schein private-labeled products. It requires demonstrated leadership and communication skills, as well as a broad understanding of label and IFU development, change management process/procedures and labeling software systems. This position must have the ability to work effectively and efficiently with all Ortho Organizers' team members, have a good understanding of global labeling regulations and requirements, and have the ability to generate creative labeling solutions as new labeling requirements unfold. Strong attention to detail, written and oral communication, teamwork and organizational skills are essential.

KEY RESPONSIBILITIES:

• Serve as Master Administrator within the labeling software systems - Bartender, Codesoft - and be fully conversant with their creation tools.


• Serve as the global labeling team member for Ortho Organizers' labeling initiatives including, but not limited to, new product development, maintenance projects and UDI tasks.


• Liaise with Regulatory Affairs team members and other cross-functional teams (i.e., Product Development, Product Management, Supply Chain, Henry Schein Brand Packaging Group) to develop/create labeling that complies with US, EU, ROW and UDI labeling regulations and requirements, as required, using Bartender and Codesoft labeling software systems.


• Serve as Subject Matter Expert (SME) in the areas of labeling and labeling change management.


• Troubleshoot and work with the appropriate IT departments (internal or Teklynx) to implement solutions related to issues with the architecture of the label database systems.


• Initiate change orders for new and revised labeling, work with suppliers' labeling coordinators to create, maintain, and implement compliant labeling, review product labeling against indicated content and approve/release labeling documentation for Production/Manufacturing label system usage.


• Manage and work efficiently with product suppliers to ensure labeling is compliant with UDI regulations, i.e., GS1 labeling formats and formulas.


• Serve as a mentor for any TSM involved with any aspect associated with labeling by providing regulation knowledge, support and training to maintain compliant labeling needs.


• Team leader on labeling projects.


• Works with Manufacturing to set up printing formats based in Bartender and/or Codesoft.


• Participate in special projects and performs other duties as required.

SKILL:

Exceptional understanding of the job and ability to apply knowledge and skills to complete a wide range of complex tasks. Complete tasks in creative and effective ways. Complete assignments and facilitate the work activities of others; may coordinate work beyond own area. Apply acquired knowledge of procedures and external regulations.

COMPLEXITY:

Consistently work on complex and sometimes unique assignments requiring independent action and a high degree of initiative to resolve issues. Make recommendations for new procedures. Analyze complex technical or non-technical problems.

SUPERVISION:

Work under minimal supervision and may act independently to determine methods and procedures on new assignments. May act as a facilitator or team leader.

Qualifications

MINIMUM WORK EXPERIENCE:

Typically 4 or more years of related experience.

PREFERRED EDUCATION:

Typically High School education, vocational training and/or on-the-job training. Bachelor's degree preferred.

GENERAL SKILLS & COMPETENCIES:

• Excellent time management skills and the ability to prioritize work


• Very good attention to detail and accuracy


• Customer service oriented and ability to work with and resolve complex issues


• Ability to plan and arrange activities


• Excellent interpersonal communication skills


• Excellent written and verbal communication skills


• Ability to maintain confidential and highly sensitive information


• Ability to work in a team environment


• Ability to multi-task


• Ability to manage conflict


• Capacity to work effectively under pressure


• Analytical thinking


• Oversee small to medium sized projects


• Identify and recommend continuous improvement opportunities


• Establish productive working relationships at multiple levels within the organization

SPECIFIC KNOWLEDGE & SKILLS:

• Understanding of regulations applicable to HSO operations.


• Broad knowledge and understanding of US, EU, ROW and UDI labeling regulations, as well as overall FDA and MDD/MDR regulations.


• Experience with Microsoft Word and Excel, Macola/ERP System, Bartender and Codesoft labeling software.


• Strong knowledge of 2D GS1 barcode formats.

PERFORMANCE REQUIREMENTS:

Typically, to advance to a new job level, TSMs must demonstrate professional behavior and should consistently be at the high-end of meets expectations or consistently exceed expectations.

TRAVEL / PHYSICAL DEMANDS:

Travel typically less than 10%. Office environment. No special physical demands required.

Henry Schein, Inc. is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.

For more information about career opportunities at Henry Schein, please visit our website at: www.henryschein.com/careers

Primary Location

:USA-CA-Carlsbad Apply Now