Product labelling Engineer

Job Responsibilities:

Label Development & Execution

• 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.