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DECLINE ALL SAVE SETTINGS ACCEPT ALL powered by: Cookie Information Specialist, Global Labelling , as well as cookies used to display content tailored to your interests. Your experience of the site and the services we are able to offer may be impacted if you do not accept all cookies. Modify Cookie Preferences Reject All Cookies Accept All Cookies About us Jobs Our People Hiring process Values Language View profile Job Description Job Alerts Link Apply now open/close Print local Share on Twitter Share on LinkedIn Send as email Specialist, Global Labelling City: Penang Country/Region: Malaysia State: Business Area: R&D Department: Regulatory Affairs Global Labelling Employment Type: Full-time Req ID: 10064 Ambu is currently looking for a 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: Diploma or Bachelor’s degree in Chemistry, Biology or a related field. Minimum 1–2 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. For more information, please visit ambu.com or follow us on LinkedIn. 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