HCLTech
Website:
hcltech.com
Job details:
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 harmonization) (preferred).
9. Understand client’s document management system, document format styling guide and adhere to all the requirements, including corporate branding Identity, Trademark, Patent claims & Registration requirements guidelines.
10. Select and use appropriate colours, images, style, font type, size, and line length of headlines, headings, text and layout, that adheres to customer requirements.
11. Keep the business leaders and stakeholders informed upfront on schedule slippages / risks foreseen if any, along with appropriate mitigation & contingency.
12. Follow client’s documentation system to review and release the final documents.
13. Good experience with colour palettes, markup preparation and Labelling verification.
14. Good Communication with customer interface for Labelling transactions Reviewing the deliverables and provide as SME support.
15. Able to understand internal/external customer requirements & communicate to the customer promptly about the status without any delay.
Key Responsibilities
1. To work closely with stakeholders to understand and refine design requirements.
2. To drive End-to-End Labelling Programs.
3. To mentor junior designers, share knowledge and expertise through training sessions and documentation.
4. To collaborate with cross functional teams and other stakeholders to align software design with overall project goals.
5. To Oversee Content & Quality, Manage Risks, Processes & Team Performance.
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