Safety & Regulatory Compliance Engineer position at GE HealthCare.| Denmark

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GE HealthCare Safety & Regulatory Compliance Engineer

Experience: General

Pattern: Full time

Country:

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Herlev....Denmark

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Job Description Summary Professional safety, EMC, environmental, wireless, and regulatory compliance activities are central to enabling the certification, and market release of medical ultrasound scanning systems in a highly regulated medical device environment. The role focuses on execution of compliance activities within an electrical and electromechanical engineering discipline and plays a key role in bringing safe, compliant products to market. GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world. Job Description Roles and Responsibilities Responsible for defining, verifying, and assuring compliance of electrical and electromechanical systems used in medical ultrasound scanning systems with applicable international and national safety, EMC, environmental, and regulatory standards in a highly regulated medical device environment. Ensuring safety, EMC, environmental, wireless, and regulatory approval of electrical and electromechanical systems for medical ultrasound scanners through specification, design review, testing, and documentation 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 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) 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 Acting as a technical authority and advisor in safety, wireless, EMC, and regulatory compliance, supporting cross‑functional stakeholders throughout the medical device lifecycle. Required Qualifications 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 E xperience 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 Self‑driven, motivated, and collaborative team player with the ability to act as a technical authority and share compliance knowledge across disciplines Excellent written and verbal communication skills in English (Danish is considered a plus) If you feel your experience does not perfectly align with every qualification listed, we encourage you to apply anyway. We value diverse backgrounds and perspectives, and we are interested in learning how your skills and experience could contribute to this role and our organization. Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support. We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity. GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or, age, disability, protected veteran status or other characteristics protected by law. #LI-MB1 Additional Information Relocation Assistance Provided: No

Safety & Regulatory Compliance Engineer job opportunity at GE HealthCare.

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