Labelling specialist

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Role
- Labelling Specialist

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:

• Proven experience in medical device labeling and regulatory documentation.

• Proficiency in Loftware Cloud and Loftware Spectrum (hands-on or working knowledge).

• Strong command of Adobe Creative Suite (Illustrator, Photoshop, etc.).

• Hands-on or working knowledge of Windchill PLM and Agile PLM systems.

• In-depth understanding of global labeling requirements, including US, Canada, EU MDR, Australia, LATAM, and EMEA regions.

• Familiarity with regulatory standards such as IEC 60601, ISO 20417, and ISO 15223.

• Experience working in multidisciplinary teams.

• Excellent interpersonal, written, and oral communication skills.

• Strong organizational and project coordination abilities.

• High attention to detail and commitment to quality.

Educational

Qualification:

• Degree preferred, MTech / BE/ BTECH( Mechanical/Bio-medical/ Eq

Good to have:
Experience in Adobe Illustrator, Adobe In-design, Adobe Photoshop, MS Office