Labeling Specialist

About the role

This position is a subject matter expert in global medical device labeling, regulations, and requirements. The Specialist will plan, develop, and execute labeling documentation and product labeling, ensuring adherence to company policy and procedures while assisting in maintaining quality control processes. The role supports EXALTA Group’s mission to maximize the number of patients served while maintaining a high level of quality and safety.

Responsibilities

• Develops, edits, reviews, and processes labeling documentation and medical device labeling following company procedures, including translation management. Labeling includes product labels, instructions for use (IFUs), patient leaflets, implant cards, and summary of safety and clinical performance (SSCPs).
• Ensures labeling documentation and labeling is professional, readable, and compliant with applicable global regulations, directives, standards, and guidance requirements.
• Works with cross-functional project teams to perform GTIN allocation.
• Assists with GUDID and EUDAMED data maintenance and submissions.
• Investigates and resolves internal and external audit findings related to labeling non-conformities.
• Supports internal and external audits specific to labeling processes and released labeling documentation and labels.
• Monitors global labeling regulations, directives, standards, and guidance requirements for changes in labeling requirements; performs gap assessments where required.
• Writes and updates standard operating procedures and work instructions to maintain compliance with applicable labeling regulations, directives, guidance, and standards.

Requirements

• Minimum of 2 years of experience in regulatory affairs or quality systems.
• BA/BS in a scientific discipline or equivalent experience.

Skills

• Proficiency in medical terminology.
• Strong understanding of regulations and guidelines related to medical devices and quality systems, including:
  • 21 CFR 820
  • MDD 93/42/EEC
  • MDR 2017/745
  • ISO 13485
• Excellent written and oral communication skills.
• Strong computer skills, project management skills, problem-solving skills, and a high attention to detail.
• Ability to work under pressure and with cross-functional teams.