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 labeling 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).

Robust 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.

Solid organizational and project coordination abilities.

High attention to detail and commitment to quality.

Educational Qualification:

Degree preferred, MTech / BE/ BTECH( Mechanical/Bio-medical/any relevant )

📌 Labeling Engineer Pune
🏢 Tata Elxsi
📍 Pune