Senior Global Labelling Specialist Regulatory & Multilingual

Ambu A/S; Malaysia; On-site; MYR 120,000 - 180,000; Full time

Job summary

Ambu A/S in Malaysia is seeking a Senior Specialist, Global Labelling to be based at the Ambu Global Hub, Penang. The role focuses on developing, reviewing and maintaining labelling in line with global regulatory requirements across regions.

You will collaborate with Regulatory Affairs, QA, R&D, and Marketing to ensure accuracy of labels, IFU, and translations, and support audits with robust documentation and version controls.

Qualifications

• Must hold a life sciences degree with 4+ years in labelling, regulatory affairs or quality in medical devices, pharma, or healthcare.
• Experience with global labelling requirements and change documentation management.
• Familiar with QA audits and regulatory standards in documentation control.
• Strong English communication; Chinese skills are a plus.

Responsibilities

• Develop, create, review, and maintain product labelling per global regulatory requirements.
• Ensure compliance with regional regulations (FDA, EU MDR) per ISO 13485.
• Coordinate labelling updates due to regulatory or product changes.
• Manage labelling change controls and documentation (Agile).
• Collaborate with Regulatory Affairs, Quality Assurance, R&D, and Marketing.
• Review and approve artwork for accuracy and translations.
• Support audits/inspections with labelling documentation and justification.
• Maintain labelling databases and version control.
• Work with external DTP and translation vendors for multilingual labelling.
• Create and maintain Master Data in GUDID and EUDAMED.

Skills

Cross-functional collaboration

Regulatory knowledge

MS Office proficiency

Education

Bachelor's degree in Chemistry or Biology

Tools

GUDID/EUDAMED experience

Job description

Ambu A/S in Malaysia is seeking a Senior Specialist, Global Labelling to be based at the Ambu Global Hub, Penang. The role focuses on developing, reviewing and maintaining labelling in line with global regulatory requirements across regions.

You will collaborate with Regulatory Affairs, QA, R&D, and Marketing to ensure accuracy of labels, IFU, and translations, and support audits with robust documentation and version controls.