Safety & Regulatory Compliance Engineer

GE Healthcare GE Healthcare · Healthcare · Herlev, Zealand, Denmark · Engineering / Technology

The role focuses on ensuring the safety, EMC, environmental, wireless, and regulatory compliance of electrical and electromechanical systems for medical ultrasound scanning systems. This involves defining, verifying, and assuring compliance with international and national standards, working with external certification bodies, and advising cross-functional teams throughout the product lifecycle in a highly regulated medical device environment.

What you'd actually do

  1. Ensuring safety, EMC, environmental, wireless, and regulatory approval of electrical and electromechanical systems for medical ultrasound scanners through specification, design review, testing, and documentation
  2. Addressing compliance of electrical systems, including power electronics, displays, cabling, grounding concepts, enclosures, non‑conductive materials, radio modules, and overall system integration within a medical device context
  3. Supporting compliance activities with external certification and approval bodies, including UL and equivalent institutes, for product listing, regulatory approvals, and wireless certifications (e.g., CE, FCC, and other regional authorities)
  4. Maintaining up‑to‑date knowledge of relevant EU Medical Device Regulation (MDR), applicable directives, international safety and EMC standards, wireless and radio regulations, and worldwide approval requirements for medical equipment
  5. Acting as a technical authority and advisor in safety, wireless, EMC, and regulatory compliance, supporting cross‑functional stakeholders throughout the medical device lifecycle.

Skills

Required

  • Bachelor's or Master's degree in Electronic Engineering or a related technical discipline
  • Advanced experience within safety, EMC, environmental, and regulatory compliance for electronic or electromechanical systems
  • Experience working 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 EMC, environmental, safety, and wireless compliance testing including collaboration with external test houses and certification bodies
  • Strong understanding of electrical system behavior, grounding concepts, cabling, enclosures, and system‑level integration from a compliance and safety perspective
  • Experience reviewing designs and test results in collaboration with Quality Assurance, identifying compliance risks, and advising engineering teams on appropriate mitigation strategies.
  • Structured, systematic, and analytical approach to compliance activities, including troubleshooting and root‑cause analysis
  • Excellent written and verbal communication skills in English

Nice to have

  • Danish language skills

What the JD emphasized

  • highly regulated medical device environment
  • highly regulated medical device environment