Job Description
1. 8–12+ years of experience in medical device / IVD labelling. Proven experience leading large-scale labelling remediation/sustenance/merger projects.
2. Interact with cross functional team spread across geographies to gather technical inputs finalize the inputs, in consent with all stakeholders.
3. Strong knowledge of: ISO 15223 / ISO 20417, EU IVDR/MDR and US FDA labelling requirements, eIFU, UDI, symbol implementation, and multi-language labelling.
4. Manage timelines, resources, risks, and stakeholder expectations. Drive prioritization across high-volume portfolios.
5. High attention to detail with a compliance-driven mindset. Good experience with Redline markup preparation and Labelling verification.
6. Proficiency in labelling/artwork tools (Adobe Illustrator, InDesign, etc.).
7. Experience in automation and digital transformation. Exposure to AI/automation in labelling workflows (preferred).
8. Experience in merger/acquisition integration (labelling harmoni...
2. Interact with cross functional team spread across geographies to gather technical inputs finalize the inputs, in consent with all stakeholders.
3. Strong knowledge of: ISO 15223 / ISO 20417, EU IVDR/MDR and US FDA labelling requirements, eIFU, UDI, symbol implementation, and multi-language labelling.
4. Manage timelines, resources, risks, and stakeholder expectations. Drive prioritization across high-volume portfolios.
5. High attention to detail with a compliance-driven mindset. Good experience with Redline markup preparation and Labelling verification.
6. Proficiency in labelling/artwork tools (Adobe Illustrator, InDesign, etc.).
7. Experience in automation and digital transformation. Exposure to AI/automation in labelling workflows (preferred).
8. Experience in merger/acquisition integration (labelling harmoni...