Regulatory Manager – IVDR Labeling

Job Title: Regulatory Manager – IVDR Labeling

Role Overview

Seeking a Regulatory Manager with hands-on EU IVDR (2017/746) labeling experience to lead regulatory compliance for IVD labeling programs. The role is responsible for label content, IFUs, UDI, symbols, labeling documentation, change control, and ensuring compliance across global markets.

Key Responsibilities

• Lead IVDR labeling compliance, regulatory strategy, and gap assessments.
• Review and approve label specifications, IFUs, and labeling documentation.
• Manage UDI (UDI-DI/UDI-PI), EUDAMED alignment, and labeling symbols.
• Assess device classification (Class A–D) and labeling impact.
• Monitor IVDR, MDCG guidance, ISO 15223-1, ISO 18113, and ISO 20417 requirements.
• Support labeling change control, audits, inspections, and post-market labeling updates.
• Collaborate with Quality, DTP, Labeling Operations, and Label Management Systems (Loftware, OPAL, NiceLabel, BarTender).
• Support Notified Body interactions and mentor junior regulatory team members.

Required Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Engineering, or related field.
• Hands-on experience in IVDR labeling within Regulatory Affairs.
• Strong knowledge of EU IVDR (2017/746), UDI, EUDAMED, device classification, IFUs, and labeling standards.
• Experience reviewing and approving labeling documentation.
• Excellent communication and stakeholder management skills.

Preferred

• Experience with Label Management Systems (Loftware, OPAL, NiceLabel, BarTender).
• Knowledge of EU MDR and pharmaceutical labeling.
• Experience with Computer System Validation (CSV) and Notified Bodies.
• Project management experience in labeling programs.