Labeling Designer
3 weeks ago
Loftware Labeling Designer/ Technical Writer
Location: Bangalore
Experience: 3-5years
Responsibilities
- B.E. in Mechanical / Electrical / Electronic Engineering / MS in engineering preferred / Equivalent Degree
- Medical device labelling specialist with 3-5 years of experience in labelling and Loftware, Priysm 360, Adobe InDesign, Illustrator.
- Good understanding on Label, IFU and technical files with respect to Annexure I & II.
- Work within labelling tools/systems to modify/create label templates
- Knowledge of Medical Device Quality System Regulations & QMS (FDA 21CFR Part 820, ISO 13485) Familiar with ISO 13485, ISO 15223, UDI, MDR, other applicable regulatory standards.
- Knowledge of EU Medical device regulation like Medical Device Directive 93/42/EEC
- Update all Labels, Pre-printed artworks, and IFUs/Manuals with UK CA. Regulation [EU MDR 2017/745]
- All Labels, Pre-printed artworks, and IFUs/Manuals to be updated in specified software's and tools.
- Collect Labels from Windchill PLM, Labeling compliance across different sites.
- Loftware Process and knowledge is appreciable
- Redlining the changes for documentation and revision update.
- Initiation of Labeling Change Management Process in PLM and support for end to end PLM approval and process
Tools : Adobe Indesign / Illustrator / Priysm / Nicelabel / Codesoft Loftwrae / Windchill
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