Specialist, Labeling Control

Job Title: Specialist, Labeling Control

Role Level: Individual Contributor (IC)

Supervisor/Manager

Title:

Senior Manager, Corporate Quality Systems

Job Location & Environment: Irvine, CA - Corporate Office



Job Description

Summary:

The Labeling Control Quality Specialist supports labeling-related elements of the Jena Valve Quality Management System (QMS) to ensure compliance with global medical device regulations and standards. This role provides quality oversight for the development, control, and validation of product labeling, including but not limited to device labels, IFUs/eIFUs, and patient implant cards, ensuring alignment with approved technical documentation and regulatory requirements.

Working cross-functionally with Regulatory Affairs and Labeling Operations, the specialist supports labeling accuracy, change control, printing processes, and investigations, while maintaining a strong focus on patient safety, regulatory compliance, and audit readiness.

Job Responsibilities:

Quality System Support Activities may include:

• Support maintenance of labeling-related processes within the QMS in alignment with 21 CFR Part 820, 21 CFR Part 801, 21 CFR Part 830 (UDI), ISO 13485:2016, and EU MDR (Regulation (EU) 2017/745), including Annex I, II, and VI requirements.
• Provide quality oversight for labeling development, review, approval, and implementation for final product labels, Instructions for Use (IFU and eIFU), and patient implant cards.
• Ensure labeling content is accurate, compliant, and consistent with approved technical documentation (Annex II), regulatory submissions, device claims, product configurations, and UDI requirements.
• Review and approve labeling to ensure compliance with ISO 15223-1 (medical device symbols), ISO 20417 (information supplied by the manufacturer), ISO 5840 (cardiovascular implant labeling), and EU MDR Annex I Chapter III labeling and IFU requirements.
• Support UDI implementation and maintenance, ensuring alignment between labeling, regulatory databases, and product identification requirements.
• Participate in labeling design and updates using Label View or similar labeling software, ensuring proper formatting, controlled data inputs, and labeling integrity.
• Ensure proper document control of labeling artwork and content, including version control, change history, and approval workflows in accordance with QMS requirements
• Support and execute labeling change control activities, including performing impact assessments related to regulatory, manufacturing, and patient safety considerations, coordinating cross-functional reviews and approvals, and ensuring controlled implementation.
• Support and/or lead investigations related to labeling, including labeling nonconformances, printing errors in both in-house and supplier-managed processes, and complaints associated with labeling content or IFU accuracy.
• Support and/or execute label validation and verification activities to ensure label content accuracy, correct UDI and product identifiers, proper use of regulatory symbols, print quality, readability, durability, barcode accuracy and scannability, and alignment between approved artwork and final printed output.
• Participate in validation of labeling processes, including supporting equipment qualification and validation activities (IQ/OQ/PQ as applicable), assisting with labeling software validation (e.g., Label View), and ensuring controlled and validated data flows between systems.
• Ensure labeling and printing processes comply with validation requirements.
• Support audits and inspections by providing labeling-related documentation and demonstrating compliance with global regulatory requirements and internal procedures.
• Contribute to continuous improvement of labeling processes and systems to enhance patient safety, product quality, and regulatory compliance.

Required

Education and Experience:

• Bachelor's degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or a related discipline
• 1-3+ years of experience in a regulated medical device environment, preferably supporting Class II or Class III devices
• Working knowledge of Quality Management Systems, including ISO 13485 and 21 CFR Part 820
• Familiarity with global medical device labeling requirements, including 21 CFR Part 801 and EU MDR Annex I and Annex VI
• Understanding of labeling standards, including ISO 15223-1, ISO 20417, and preferably ISO 5840 for cardiovascular devices
• Experience or exposure to UDI systems, labeling traceability, labeling control processes, artwork management, and document control systems
• Experience with Label View or similar labeling software preferred
• Experience supporting or participating in label validation and verification activities, including inspection of printed labels, verification of labeling content against approved artwork, barcode and UDI verification, and basic process validation concepts applied to labeling systems and printing processes
• Familiarity with label validation practices, including barcode verification, print…