Labeling Designer

3 weeks ago


Bengaluru, Karnataka, India L&T Technology Services Full time

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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