Senior Global Labelling Specialist

Ambu Sdn Bhd; Penang; On-site; MYR 120,000 - 180,000; Full time

Job summary

Ambu is currently looking for a Senior Specialist, Global Labelling to be based in Ambu Global Hub, Penang. You will develop, review and maintain product labelling in line with global regulatory requirements, and collaborate with Regulatory Affairs, QA, R&D, and Marketing to ensure accuracy and compliance.

You will coordinate label updates, manage change controls, support audits, and maintain labelling databases, including multilingual labeling with external vendors.

Qualifications

• Bachelor’s degree in chemistry, biology or related field.
• 4+ years of experience in labelling, regulatory affairs, or quality in medical devices, pharmaceuticals, or healthcare industries.
• Experience with global labelling requirements and change document management systems.
• Understanding of documentation principles to ensure QA audits and regulatory compliance.
• Excellent interpersonal communication, organizational, coordination, and problem-solving skills, esp. in cross-functional teams.
• Work independently, structured, systematic and willing to learn.
• Proficient in MS Office Word, Excel, Adobe Acrobat App, Outlook, PPT.
• Experience in global or multi-region environment.
• Be proficient in written and spoken English at negotiation level.
• Proficiency in reading, writing, and speaking Chinese is an added advantage.

Responsibilities

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

Skills

Labelling

Regulatory affairs

Quality assurance

Documentation management

Cross-functional collaboration

MS Office

English negotiation

Chinese language (advantage)

Attention to detail

Project management

Education

Bachelor’s degree in chemistry or biology

Tools

GUDID

EUDAMED

MS Office

Adobe Acrobat

Job description

Ambu is currently looking for a Senior Specialist, Global Labelling to be based in Ambu Global Hub, Penang. You will develop, review and maintain product labelling in line with global regulatory requirements, and collaborate with Regulatory Affairs, QA, R&D, and Marketing to ensure accuracy and compliance.

You will coordinate label updates, manage change controls, support audits, and maintain labelling databases, including multilingual labeling with external vendors.