Medical Device Regulatory Specialist

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

JOB LOCATION-Pune

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

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:

• Medical device labeling, labeling regulations, 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.

• 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

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