L&T Technology Services Hiring Medical Writers

L&T Technology Services Hiring Medical Writers

23 February, 2022

Medical device labelling specialist with 2-5 years of experience in labelling and regulatory affairs.

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 Medical device regulation like

  • Prisym 360 labeling support for all sites
  • Workflow’s creation considering all cross functional department stakeholders.
  • EU MDR wave2 support for all customer locations
  • All applicable Labels, Pre-printed materials and IFUs will be thoroughly analyzed for the EU MDR gaps.
  • Documents like GSPRS, Tech Doc, CERs and Risk Management files will be thoroughly analyzed.
  • Mitigate all the identified gaps (like Limitations, Intended Users, Patient Population, Serious incident statements, Clinical Benefits and Performance Characteristics) per EU MDR regulations
  • UK CA (UK Conformity Assessed) support
  • Medical Device Directive 93/42/EEC
  • Medical Device Regulation [EU MDR 2017/745]

Skills

  • Prisym 360
  • EU MDR implementation for labeling (Labels, Pre-printed artworks, IFUs)
  • UK CA
  • Adobe InDesign
  • Bartender
  • MS Office

Preferable : Minimum 2 years’ experience on working with one labelling software.

  1. Excellent written (Technical Writing) and Verbal communication skills along with experience in updating Instructions for use, User Manuals etc

Apply through below link

(3) Jobs based on your Profile | LinkedIn

Leave a Reply

Your email address will not be published. Required fields are marked *