Product labelling Engineer

UST; Pune District; On-site; INR 700,000 - 1,100,000; Full time

Job summary

UST seeks a labeling specialist in Pune to develop and maintain product labels, IFUs, and regulatory markings for medical devices across regions. You will coordinate changes, ensure traceability, and support NPI and product releases, working with regulatory, quality, and manufacturing teams.

The role requires 4–7 years in medical device labeling or related fields, with strong documentation and stakeholder management skills. This position is based in Pune, in a regulated environment.

Qualifications

• Bachelor’s degree in Engineering (Mechanical, Electronics, Biomedical, Systems, Industrial, or related field).
• 4–7 years in medical device labeling, regulatory affairs, quality engineering, or related fields.
• Knowledge of medical device regulations and standards.
• Experience in a regulated environment (FDA, ISO 13485, EU MDR).
• Strong documentation and change management skills.
• Excellent communication and stakeholder management skills.

Responsibilities

• Develop and maintain product labels, packaging labels, IFUs, regulatory markings, and country-specific labeling artifacts.
• Create and update labeling requirements specifications based on regulatory, safety, engineering, and marketing requirements.
• Support new product introductions (NPI), product changes, and sustaining engineering activities.
• Generate and manage labeling content within applicable systems and workflows.
• Coordinate labeling reviews and approvals with cross-functional stakeholder.
• Support labeling-related Change Requests (CRs), Engineering Changes, and Product Releases.
• Drive labeling deliverables through change control processes while meeting project timelines.
• Coordinate with configuration management, manufacturing, quality, and regulatory teams.
• Support labeling verification and validation activities.
• Ensure label accuracy, traceability, and consistency across product configurations and regions.
• Participate in Formal Label Reviews (FLR) and documentation reviews.

Skills

Communication

Documentation

Change management

Regulatory knowledge

Education

Bachelor’s degree in Engineering (Mechanical, Electronics, Biomedical, Systems, Industrial)

Job description

• Develop and maintain product labels, packaging labels, IFUs, regulatory markings, and country-specific labeling artifacts.
• Create and update labeling requirements specifications based on regulatory, safety, engineering, and marketing requirements.
• Support new product introductions (NPI), product changes, and sustaining engineering activities.
• Generate and manage labeling content within applicable systems and workflows.
• Coordinate labeling reviews and approvals with cross-functional stakeholder.

Change Management

• Support labeling-related Change Requests (CRs), Engineering Changes, and Product Releases.
• Drive labeling deliverables through change control processes while meeting project timelines.
• Coordinate with configuration management, manufacturing, quality, and regulatory teams.

Verification & Validation

• Support labeling verification and validation activities.
• Ensure label accuracy, traceability, and consistency across product configurations and regions.
• Participate in Formal Label Reviews (FLR) and documentation reviews.

Required Qualifications

• Bachelor's degree in Engineering (Mechanical, Electronics, Biomedical, Systems, Industrial, or related field).
• 4 to 7 years of experience in medical device labeling, regulatory affairs, quality engineering, product engineering, or related fields.
• Knowledge of medical device regulations and standards.
• Experience working in a regulated environment (FDA, ISO 13485, EU MDR).
• Strong documentation and change management skills.
• Excellent communication and stakeholder management skills.