Regulatory Labeling Specialist I
Core
Ensures compliance of medical device labels, IFUs, and UDI initiatives for Henry Schein Products Group across US, EU, and Canadian markets.
Role type
Entry-level Regulatory Labeling Specialist
Builds
Compliant product labels and Instructions for Use (IFUs) for dental and medical device products
Domain
Medical devices / Regulatory compliance
Required skills
US/EU/Canada labeling regulations, FDA/Health Canada/MDD/MDR compliance, labeling software systems (Codesoft, Teklynx), change order management, proofreading, data entry
Preferred skills
Experience with Codesoft or Teklynx, internship experience, Bachelor's degree in related discipline
Technologies
Codesoft, Teklynx, Microsoft Office
Responsibilities
Support data entry aspects of device labeling process, gather information for internal change orders, review and approve/release labeling documentation, support label and system updates, participate in global labeling initiatives including new product development and UDI tasks
Seniority
Entry-level, hands-on IC
