Job Title
Safety Compliance Engineer
Job Description
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 recent 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.
Regulatory & Compliance
• 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.
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.
Process Improvement
• 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.
Required Qualifications
• Bachelor's degree in Engineering (Mechanical, Electronics, Biomedical, Systems, Industrial, or related field).
• 3 to 7 years of experience in medical device labeling, regulatory a
📌 Safety Compliance Engineer (Pune)
🏢 Philips
📍 Pune