Henry Schein Inc

Regulatory Labeling Specialist I


PayCompetitive
LocationCarlsbad/California
Employment typeFull-Time

This job is now closed

  • Job Description

      Req#: R125851

      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 Ortho Organizers’ and Ortho Technology 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 and Ortho Technology 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 - Bartender, Codesoft – when assigned by lead.
      • 15% Works with Manufacturing to set up printing formats based in Bartender and/or Codesoft.
      • 15% Support label and system updates as required, using Bartender and Codesoft labeling software systems.
      • 7.5% Participates as the global labeling team member for Ortho Organizers and Ortho Technology’s 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 0 years of professional experience; Internship experience. Typically an entry-level graduate.

      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

      SPECIFIC KNOWLEDGE & SKILLS:

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

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

      Vaccine Requirement

      Candidates for this requisition are required to be fully vaccinated against COVID-19 (i.e., 2 weeks after completing their initial COVID-19 vaccination series) pursuant to state/local law. These standards and/or requirements may vary from those established by the Company. In some jurisdictions there may be an exception for those seeking a medical or religious accommodation. If you require an accommodation, please inform the recruiter or hiring manager.

      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

  • About the company

      Henry Schein, Inc. is an American distributor of health care products and services with a presence in 32 countries.