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).
- Robust documentation and change management skills.
- Excellent communication and stakeholder management skills.

📌 Product labelling Engineer (Maharashtra)
🏢 UST
📍 Maharashtra