Safety & Regulatory Compliance Engineer

Job summary

This role focuses on ensuring compliance with safety, EMC, environmental, and regulatory standards for medical ultrasound scanning systems in a highly regulated environment. The engineer will be responsible for executing compliance activities within electrical and electromechanical engineering disciplines to facilitate the certification and market release of medical devices.

Qualifications

• Bachelor’s or Master’s degree in Electronic Engineering or a related technical field
• Experience with medical devices or safety-critical products in regulated environments is advantageous
• Strong understanding of IEC 60601 series standards related to electrical safety, EMC, and risk management for medical equipment
• Familiarity with EMC, environmental, safety, and wireless compliance testing, including collaboration with external certification bodies
• Self-motivated team player with the ability to act as a technical authority and share knowledge across teams
• Proficient in written and verbal communication in English

Responsibilities

• Define, verify, and ensure compliance of electrical and electromechanical systems with applicable safety and regulatory standards
• Oversee safety, EMC, environmental, and regulatory approvals through specification, design review, testing, and documentation
• Support compliance activities with external certification bodies for product listings and regulatory approvals
• Maintain current knowledge of EU Medical Device Regulation (MDR) and international safety standards
• Act as a technical advisor in safety and regulatory compliance throughout the medical device lifecycle

Skills

• Strong analytical and problem-solving skills
• Excellent communication and collaboration abilities

Education

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

Tools

• Familiarity with compliance testing tools and methodologies