Regulatory Labeling and Documentation Expert

Skills - working experience on various labelling systems like P360, Loftware, Kallick etc and know end-to-end labelling process.

We are looking for a candidate having working experience Medical device labeling, understand basic labeling regulations and hands on experience on advanced labeling tools.

• Advanced Labeling tools – Prism 360 (P360), Loftware, Bartender, NiceLabel, Enlabel, Kallik etc.
• Basic Labeling tools – Adobe illustrator, Adobe In Design.
• Basic Labeling regulations- EU MDR, ISO 15223, ISO 20417 etc.
• PLM tools- Agile PLM, Windchill or any other equivalent PLM.

Key Responsibilities

• Design, re-design, and maintain medical device labels in line with brand guidelines and regulatory standards
• Ensure compliance with FDA, EU MDR, UDI, ISO 13485, and other applicable regulations
• Develop and manage label templates using Loftware Spectrum® 4.6 / 4...