Senior Specialist, Global Labelling

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.

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 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 (IFU, Quick guide).

Work with external translation vendor to ensure accuracy in multilingual labelling (IFU).

Create and maintain Master Data (upload in GUDID and EUDAMED).

Suggested candidate profile:

Skills and experiences can be earned in many different ways, and we understand that the best fit for the role cannot be prescribed on paper. You are however likely to succeed in this position if you:

Bachelor’s degree in chemistry, Biology or a 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.

Have understanding of the general principles of documentation, incl. experience in maintaining it to ensure compliance with QA audits and regulatory standards.

Demonstrates excellent interpersonal communication, organizational, coordination, and problem-solving skills, especially in cross-functional teams.

Work independently, structured , systematic and wilingness to learn.

Ability to manage multiple tasks and urgent timelines.

Proficient in MS Office Word, Excel, Adobe Acrobat App, Outlook, PPT preferred.

Experience working in a global or multi-region environment.

Be proficient in written and spoken English at negotiation level.

Proficiency in reading, writing, and speaking Chinese will be considered an added advantage.

Unlock job insights

Hirer responsiveness Salary match Number of applicants

Pharmaceuticals, Biotechnology & Medical Devices 1,001-5,000 employees

About Ambu

Since 1937, breakthrough ideas have driven our work to bring efficient healthcare solutions to life within our fields of excellence: Anaesthesia, Patient Monitoring & Diagnostics and Emergency Care. Millions of patients and healthcare professionals worldwide depend and rely on the functionality and performance of our products.

We are dedicated to improving patient safety and determined to advance single-use devices.

The manifestations of our efforts range from early inventions like the Ambu Bag™ resuscitator and the legendary BlueSensor™ electrodes to our latest landmark solutions such as the aScope™ endoscope – the world’s first single-use flexible video scope. Our commitment to bringing new ideas and superior service to our customers has made Ambu one of the most recognised medico-technical companies in the world.

Our head office is situated near Copenhagen in Denmark. Ambu employs approximately 4,200 people in Europe, North America, and the Asia Pacific.

For more information, please visit www.ambu.com.

About Ambu

Since 1937, breakthrough ideas have driven our work to bring efficient healthcare solutions to life within our fields of excellence: Anaesthesia, Patient Monitoring & Diagnostics and Emergency Care. Millions of patients and healthcare professionals worldwide depend and rely on the functionality and performance of our products.

We are dedicated to improving patient safety and determined to advance single-use devices.

The manifestations of our efforts range from early inventions like the Ambu Bag™ resuscitator and the legendary BlueSensor™ electrodes to our latest landmark solutions such as the aScope™ endoscope – the world’s first single-use flexible video scope. Our commitment to bringing new ideas and superior service to our customers has made Ambu one of the most recognised medico-technical companies in the world.

Our head office is situated near Copenhagen in Denmark. Ambu employs approximately 4,200 people in Europe, North America, and the Asia Pacific.

For more information, please visit www.ambu.com.

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