Label Manager

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 / 4.2 - Support label change management, version control, and documentation - Collaborate with Regulatory Affairs, Quality, Packaging, and Manufacturing teams - Prepare and maintain labeling-related regulatory documentation - Troubleshoot labeling system issues and support validation activities

Required Skills & Qualifications

- Proven experience in medical device labelling and regulatory documentation - Strong working knowledge of Loftware Spectrum® (v4.6 / v4.2) - Hands-on or working experience with Loftware Cloud - Good understanding of UDI requirements, symbols, barcodes, and IFU labeling - Experience with labeling systems such as Loftware, P360, Kallick, or similar - Strong attention to detail and compliance-driven mindset

⭐ Preferred Qualifications

- Experience in label validation (IQ/OQ/PQ) - Familiarity with SAP / PLM / ERP integrations - Exposure to global labeling regulations (US, EU, APAC) - Location-Pune