EU MDR Consultant
Experience: 1 to 4 Years'
Location: Chennai
Skills and Experience
- Labeling & Packaging Design Tools – enLabel, Adobe InDesign, Adobe Photoshop, Adobe Illustrator.
- Label change management Process.
- End-End label operations and label change control management.
- Label Standards - ISO 15223-1, ISO 7000, EN 60601-1, IECTR 60878.
- Labeling Regulations - EU MDR, EU IVDR, 21CFR Part 201.
Responsibilities in EU MDR Projects
- Art work creation for device label, blister package and shipping carton.
- Developing multi pages IFU/PIC and creating product illustration.
- Label requirement checklist creation [EU MDR, Annex I- Chapter 3].
- Mark-up creation - update label content, symbols and UDI creation.
- Label gap assessment and impact analysis [Pareto Chart 80/20 Rule].
- Label quality control, review and PLM upload.
