Job Role:

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.
- Support Label Verification & Validation (V&V;), Formal Label Reviews (FLR)
- 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.
- Robust 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).

📌 Labeling Engineer (Pune)
🏢 Tata Elxsi
📍 Pune