Department: Regulatory Affairs Global Labelling

Employment Type: Full-time

Ambu is currently looking for a Specialist, Global Labelling to be based in Ambu Global Hub, Penang.

Key responsibilities

Your main responsibilities will include:

• Develop, create, review, and maintain product labelling (e.g. IFU, labels) in line with global regulatory requirements.
• Ensure compliance with regional regulations (e.g. FDA, EU MDR standard according to ISO 13485).
• Coordinate labelling updates due to regulatory changes, product changes, or safety updates.
• Manage labelling change controls and documentation (Agile).
• Collaborate with cross-functional teams such as Regulatory Affairs, Quality Assurance, Reseach and Developemnt (R&D), and Marketing.
• Review and approve artwork to ensure accuracy, consistency, and completeness (e.g. symbols, translations, formatting).
• Support audits and i...