Senior Specialist, Global Labelling 1

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

Department: Regulatory Affairs Global Labelling

Employment Type: Full-time

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.

About Ambu

Ambu has been bringing the solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anaesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America and the Asia Pacific.