Labeling Engineer

Tata Elxsi, Inc.; Pune District; On-site; INR 600,000 - 1,100,000; Full time

Job summary

Tata Elxsi, Inc. is hiring a Labeling Engineer (Medical Devices) to lead the development, verification, and lifecycle management of medical device labels, IFUs, and packaging artwork from Pune.

The role ensures adherence to global regulatory requirements and design control processes while supporting product changes and regulatory reviews. The ideal candidate will have 3+ years in Medical Device labeling, strong knowledge of FDA/EU requirements, and experience with PLM systems and labeling tools.

Qualifications

• Bachelor's degree in a relevant field and 3+ years of experience in Medical Device Labeling or related regulatory documentation.
• Experience with Product Labels, Packaging Labels, IFUs, Operations Manuals, and technical documentation.
• Knowledge of FDA labeling requirements, EU MDR, ISO 13485, UDI, and related standards.
• Experience supporting Notified Body submissions and regulatory audits.
• Strong analytical skills and cross-functional collaboration capabilities.

Responsibilities

• Develop and maintain Product Labels, Packaging Labels, IFUs, and service documentation.
• Collaborate with Regulatory Affairs, Quality, Engineering, Packaging, Manufacturing, and Marketing to define labeling requirements.
• Create and maintain labeling strategy documents and labeling plans for new product development and sustaining activities.
• Perform labeling gap assessments and remediation for regulatory and market-specific needs.
• Create and manage labeling artwork using approved tools and ensure content accuracy.
• Coordinate localization and distributor labeling requirements for different markets.
• Drive change management activities related to labeling (ECN, ECO, LCE, CAPA).
• Support regulatory submissions and Notified Body reviews with labeling documentation.

Skills

Medical Device Labeling

Regulatory Documentation

Product Development Processes

Analytical Skills

Cross-functional Collaboration

Education

Bachelor's degree in Mechanical Engineering

Packaging Engineering

Biomedical Engineering

Industrial Engineering

Tools

Loftware

Windchill PLM

DOORS

Job description

The Labeling Engineer is responsible for the development, maintenance, verification, and lifecycle management of medical device labels, packaging artwork, Instructions for Use (IFUs), Operations Manuals, and related technical publications. The role ensures compliance with global regulatory requirements, medical device standards, design control processes, and quality management system requirements while supporting product development, product changes, global registrations, and Notified Body reviews.

Role - Labeling Engineer (Medical Devices)

Location - Pune

Experience - 3 to 9 Years

Key Responsibilities

• Develop and maintain Product Labels, Packaging Labels, Ancillary Labels, Box Carton Artwork, IFUs, Operations Manuals, and Service Documentation.
• Collaborate with Regulatory Affairs, Quality, Engineering, Packaging, Manufacturing, and Marketing teams to gather and define labeling requirements.
• Create and maintain Product Labeling Strategy (PLS) documentation and labeling plans for new product development and sustaining activities.
• Perform Label Gap Assessments and implement remediation activities arising from regulatory, product, packaging, or market-specific requirements.
• Create and manage labeling artwork using approved graphic and authoring tools.
• Manage country-specific localization and distributor labeling requirements.
• Drive labeling-related change management activities, including ECN, ECO, LCE, CAPA, and regulatory-driven changes.
• Conduct impact assessments and support root cause investigations and corrective action implementation for labeling-related issues.
• Manage document review, approval, and release activities through PLM systems.
• Support technical documentation and labeling packages for regulatory submissions and Notified Body reviews.
• Coordinate and perform in-country reviews of translated labels, IFUs, manuals, and artwork with Local Regulatory Affairs representatives to ensure content accuracy and regulatory compliance.
• Support continuous improvement initiatives for labeling processes, systems, and workflows.

Mandatory Skills & Qualifications

• Bachelor's Degree in Mechanical Engineering, Packaging Engineering, Biomedical Engineering, Industrial Engineering, or related field.
• 3+ years of experience in Medical Device Labeling, Technical Publications, Packaging Artwork, or Regulatory Documentation.
• Strong understanding of Medical Device Design Control and Product Development Processes.
• Experience developing and maintaining: Product Labels, Packaging Labels, IFUs, Operations Manuals, Technical Documentation
• Knowledge of: FDA Medical Device Labeling Requirements, EU MDR, ISO 13485, ISO 15223-1 Medical Device Symbols, UDI Requirements, IFU and Medical Device Labeling Standards
• Experience supporting Notified Body submissions, reviews, and audit activities.
• Experience with label verification, validation, and change control processes.
• Strong analytical skills with the ability to identify issues, perform root cause analysis, and drive corrective actions.
• Experience working with cross-functional stakeholders across Regulatory, Quality, Engineering, Packaging, and Manufacturing teams.

Preferred Skills

• Experience with Loftware Labeling Platform.
• Experience with Windchill PLM systems.
• Knowledge of Packaging Development and Artwork Approval Processes.
• Experience with Localization and Translation Management.
• Understanding of Software GUI and SaMD labeling requirements.
• Experience with Regulatory Submissions and Global Product Registrations.
• Knowledge of IEC 60601 and related medical device safety standards.
• Familiarity with Requirement Management tools (e.g., DOORS).