Safety Compliance Engineer

Safety Compliance Engineer

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 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.

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 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.

Minimum required Certification:
N/A

Preferred Education:
N/A

Preferred Experience:
N/A

Preferred Certification:
N/A

Preferred Skills:

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

How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.
About Philips
Are you ready to do the work of your life to help the lives of others? Learn more about our business, discover our rich and exciting history and learn more about our purpose.
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care.

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Experience Level

Senior Level