Senior Specialist – Biocompatibility, Reprocessing & Chemical Compliance job opportunity at GE HealthCare.

Home Jobs In Denmark Tag: Reprocessing & Chemical Compliance Senior Specialist – Biocompatibility, Reprocessing & Chemical Compliance position at GE HealthCare


DatePosted 6 Days Ago bot
GE HealthCare Senior Specialist – Biocompatibility, Reprocessing & Chemical Compliance
Experience: Highly Experienced
Pattern: full-time
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Reprocessing & Chemical Compliance

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loacation Herlev, Denmark
loacation Herlev....Denmark

Job Description Summary Join SVG as a Senior Specialist – Biocompatibility, Reprocessing & Chemical Compliance Location: Herlev, Denmark (On-site with flexibility) Are you passionate about ensuring the safety and compliance of advanced medical technology? At Surgical Visualization and Guidance (SVG), we design, manufacture, and maintain cutting-edge medical scanner systems that make a real difference in healthcare worldwide. We’re seeking a Senior Specialist to lead biocompatibility evaluations, chemical compliance, and cleaning/disinfection requirements - critical elements in delivering safe, reliable products to patients and clinicians. GE HealthCare is a leading global medical technology and digital solutions innovator with over 100 years of healthcare industry experience and around 50,000 employees globally. We enable clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by our Edison intelligence platform. We operate at the center of an ecosystem working toward precision health - digitizing healthcare, helping drive productivity and improving outcomes for patients, providers, health systems and researchers around the world. Job Description Roles and Responsibilities Lead biocompatibility assessments in accordance with applicable standards, ensuring materials meet the highest safety requirements. Develop and validate cleaning and disinfection instructions for reusable components, supporting global hygiene and patient safety standards. Ensure compliance with relevant regulations and directives, including chemical characterization and risk assessments for our scanner systems. Collaborate with Engineering, Quality, Regulatory, and Manufacturing teams to embed compliance throughout product development and lifecycle. Prepare and maintain documentation for regulatory and quality compliance, supporting new product introductions and installed base maintenance. Required Qualifications Master’s degree in Biomedical Engineering, Materials Science, Chemistry, or a related discipline. Min. 5 years of experience in the medical device industry, with knowledge of biocompatibility, chemical safety, and reprocessing validation - and a strong motivation to deepen expertise in these areas. Ability to interpret requirements and translate them into actionable steps that support development and maintenance of ultrasound scanners. A solid understanding of standards and regulations such as ISO 10993, ISO 17664, REACH, RoHS, WEEE, and ISO 14971 (Risk Management) is preferred. Excellent analytical, communication, and documentation skills. Proven ability to manage projects independently and mentor junior team members. Fluent in verbal and written English. It is an advantage if you can speak and write Danish. Preferred Certifications/Training and/or Exposure ISO 13485 Quality Management Systems ISO 10993 Biocompatibility REACH, RoHS, WEEE compliance ISO 14971 Risk Management Toxicology Training or exposure in one or two of these areas is sufficient - we expect your strong technical background will enable you to quickly gain experience in the remaining areas on the job. Why Join GEHC/SVG? Impact healthcare globally by ensuring the safety and compliance of life-saving medical devices. Work in a collaborative, innovative environment where your expertise shapes the future of medical technology. Enjoy flexibility and growth opportunities , including professional development and cross-functional exposure. Be part of a company that values quality, integrity, and continuous improvement . 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. Additional Information Relocation Assistance Provided: No

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