Labelling specialist

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Role-

Job Description :

The Label Designer for re-designing medical device labels as per brand standard guidelines for regulatory compliance. Label designer should be well-versed in Loftware Spectrum® 4.6 version or 4.2 version. Provide creative solutions in medical device labelling and packaging design and validation.

Title : Label Specialist

Experience : 5 - 15 years

Domain : Medical Device

Location : Pune

Key Responsibilities :

• Develop and manage product labeling to ensure compliance with FDA, EU MDR, Health Canada, Global countries, UDI, and standards such as ISO 20417 and ISO 15223.
• Collaborate with cross-functional teams to develop label content and support the creation of Instructions for Use (IFU) and Operations Manuals.
• Create labelling input and specification documents.
• Lead and participate in design review meetings for label artwork, specifications, IFUs, and marketing collaterals.
• Develop and update labeling specifications, artwork files, and supporting documentation; coordinate translation requests.
• Review First Article Inspection (FAI) reports, verify final content, and support barcode grading and qualification.
• Provide support to resolve technical and operational labeling issues.
• Conduct design reviews for updated documents and complete Document Change Request (DCR) reviews in a timely and objective manner.
• Create and route Labeling Change order in PLM and ensure effective change management coordination using PLM tools such as Windchill and Agile.

Required Skills & Experience :

Educational Qualification :

Good to have :