Regulatory Labeling Specialist I

This position is responsible for participating in medical device labeling projects, including, but not limited to product labels, IFUs, translations, labeling software systems and UDI initiatives, as necessary, to market Henry Schein Products Group (HSPG) products.  It requires demonstrated leadership and communication skills, strong attention to detail and organizational skills, strong communication, analytical, proofreading, computer, and cross-functional collaboration skills, broad knowledge and understanding of US, EU, and UDI labeling regulations, as well as overall FDA, Health Canada and MDD/MDR regulations, 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 HSPG team members. A Strong attention to detail, written and oral communication, teamwork and organizational skills are essential.

KEY RESPONSIBILITIES: 

• 20% Works cross functionally to support all data entry aspects of device labeling process.
• 20% Gather all supporting information for internal change orders for new and revised labeling to create, maintain, and implement compliant labeling, review product labeling against indicated content and approve/release labeling documentation for Production/Manufacturing label system usage.
• 15% Supports with tasks associated with labeling software systems – Codesoft or other – when assigned by lead.
• 15% Works with Manufacturing to set up printing formats based in Codesoft or other.
• 15% Support label and system updates as required, using Codesoft or orther labeling software systems.
• 7.5% Participates as the global labeling team member for HSPG labeling initiatives including, but not limited to, new product development, maintenance projects and UDI tasks.
• 7.5% Participate in special projects and performs other duties as required.

MINIMUM WORK EXPERIENCE:  

Typically 1+ years of related professional experience; Internship experience. Typically an entry-level graduate. Experience with labeling any labeling software or labeling systems is preferred, and experience with Teklynx and CodeSoft are differentiating qualifications.

PREFERRED EDUCATION:  

Typically a Bachelor's Degree or global equivalent in related discipline.

GENERAL SKILLS & COMPETENCIES:  

• Learning tools, systems, and procedures
• Basic planning/organizational skills and techniques
• Basic analysis and problem solving skills
• Basic verbal and written communication skills
• Proficient in Microsoft products
• Change order management within a quality management system

SPECIFIC KNOWLEDGE & SKILLS:  

Understanding of regulations applicable to HSPG operations.                                                                      
TRAVEL / PHYSICAL DEMANDS:

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

Travel typically less than 10%. Office environment. This position requires some lifting (at least 50lbs) and possibly making large deliveries to clinics located within the same building of the dental store. 

The posted range for this position is $44,150 to $68,985 which is the expected starting base salary range for an employee who is new to the role to fully proficient in the role. Many factors go into determining employee pay within the posted range including prior experience, current skills, location/labor market, internal equity, etc. 

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

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