Safety & Regulatory Compliance Engineer (Medical Devices, Remote)

Job summary

This role focuses on ensuring compliance with safety, EMC, environmental, and regulatory standards for electrical and electromechanical systems in medical ultrasound scanning systems within a highly regulated environment.

Qualifications

• Bachelor’s or Master’s degree in Electronic Engineering or a related technical field
• Extensive experience in safety, EMC, environmental, and regulatory compliance for electronic or electromechanical systems
• Familiarity with medical devices or other safety-critical products in regulated settings
• In-depth knowledge of IEC 60601 series standards and CE marking
• Practical experience in compliance testing and collaboration with certification bodies
• Strong understanding of electrical system behavior and integration from a compliance perspective
• Proficient in reviewing designs and test results, identifying compliance risks, and advising on mitigation strategies
• Structured and analytical approach to compliance activities
• Excellent communication skills in English; Danish is a plus

Responsibilities

• Define, verify, and assure compliance of systems with applicable standards
• Ensure safety and regulatory approval through design review, testing, and documentation
• Support compliance activities with external certification bodies for product approvals
• Maintain knowledge of relevant regulations and standards for medical equipment
• Act as a technical authority and advisor in compliance matters across teams

Skills

• Strong analytical and troubleshooting skills
• Self-motivated and collaborative team player
• Ability to communicate complex compliance issues effectively

Education

• Bachelor’s or Master’s degree in Electronic Engineering or a related technical discipline

Tools

• Familiarity with compliance testing tools and methodologies