Labeling Designer

L&T Technology Services; Bengaluru; On-site; INR 600,000 - 1,000,000; Full time

Job summary

A leading technology services firm in India is looking for a candidate at the mid-senior level to handle label template modifications in compliance with FDA and EU medical regulations. The role involves updating label artworks, initiating the labeling change-management process, and providing support for PLM approvals. Candidates should have knowledge of relevant regulatory standards and experience in labeling tools. This is a full-time position with competitive compensation.

Qualifications

• Familiarity with FDA, ISO regulations, and EU Medical Device regulations is essential.
• Experience with labeling tools and change management processes.

Responsibilities

• Modify and create label templates in labeling tools.
• Ensure compliance with regulatory standards in labeling.
• Support PLM approval and process for labeling changes.

Job description

Responsibilities

• Work within labeling tools/systems to modify/create label templates.
• Familiar with FDA 21CFR Part 820, ISO 13485, ISO 15223, UDI, MDR, and other applicable regulatory standards.
• Knowledge of EU Medical Device regulation, such as Medical Device Directive 93/42/EEC.
• Update all labels, pre‑printed artworks, and IFUs/Manuals with UK CA regulation (EU MDR 2017/745).
• Initiate labeling change‑management process in PLM and provide end‑to‑end support for PLM approval and process.

Contact

Email: [e-mail]

Seniority Level

Mid‑Senior level

Employment Type

Full‑time