Senior Specialist I, Global Labelling
Ambu · George Town
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:
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- 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.
- Good project management and organizational skills.
- 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.