Safety & Regulatory Compliance Engineer

Job summary

This role focuses on ensuring compliance of electrical and electromechanical systems used in medical ultrasound scanning systems within a highly regulated medical device environment. The engineer will be responsible for executing compliance activities to bring safe and compliant products to market.

Qualifications

• Bachelor’s or Master’s degree in Electronic Engineering or a related technical discipline
• Advanced experience in safety, EMC, environmental, and regulatory compliance for electronic or electromechanical systems
• Experience with medical devices or other high-reliability, safety-critical products in regulated environments
• Solid knowledge of IEC 60601 series standards, including electrical safety, EMC, and risk management aspects applicable to medical electrical equipment
• Experience with CE marking
• Practical experience with compliance testing and collaboration with external certification bodies
• Strong understanding of electrical system behavior and system-level integration from a compliance perspective
• Experience in reviewing designs and test results, identifying compliance risks, and advising engineering teams
• Structured and analytical approach to compliance activities
• Excellent written and verbal communication skills in English (Danish is a plus)

Responsibilities

• Define, verify, and assure compliance of systems with applicable safety, EMC, environmental, and regulatory standards
• Ensure safety and regulatory approval of systems through specification, design review, testing, and documentation
• Support compliance activities with external certification bodies for product listing and regulatory approvals
• Maintain knowledge of relevant regulations and standards for medical equipment
• Act as a technical authority and advisor in safety and compliance, supporting cross-functional stakeholders

Skills

• Self-driven, motivated, and collaborative team player
• Ability to share compliance knowledge across disciplines

Education

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

Tools

• Familiarity with compliance testing tools and methodologies