Safety Compliance Engineer

Overview

The Safety Compliance Engineer develops and maintains medical device labeling and supports regulatory compliance, change management, verification and validation, and labeling process improvements.

What you'll do

• 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.
• Ensure medical device labeling complies with global regulations, including FDA, EU MDR, ISO 15223-1, IEC 60601 requirements, UDI requirements, and country-specific regulations.
• Support regulatory submissions and audits by providing labeling evidence and documentation.
• Participate in labeling risk assessments and verification activities.
• 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.
• Identify opportunities to improve labeling processes, tools, and operational efficiency.
• Support KPI monitoring and continuous improvement initiatives.
• Contribute to standardization and automation efforts in labeling workflows.

What you'll need

• Bachelor's degree in Engineering (Mechanical, Electronics, Biomedical, Systems, Industrial, or related field).
• 3 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.

Nice to have

• Regulatory Compliance.
• Labeling Development.
• Change Control Management.
• Risk-Based Thinking.
• Attention to Detail.
• Problem Solving.
• Cross-Functional Collaboration.
• Project Execution.
• Continuous Improvement.
• Communication & Influence.

Details

• Location: Pune.
• Office-based teams work in-person at least 3 days per week.
• Onsite roles require full-time presence in the company’s facilities.
• Field roles are generally performed outside the company’s main facilities, at customers’ or suppliers’ locations.