In this role you will make sure our products are compliant with the EU Medical Devices Regulation (MDR), US FDA requirements and many other global regulations. GE HealthCare medical devices meet ISO 13 485 quality management system and many other international requirement standards.
GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. 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 DescriptionResponsibilities:
Prepare regulatory authority submissions and support the medical device premarket registrations.
Make sure devices meet applicable global regulatory requirements before placing them on markets and update the related documentation.
Participate in improving the process and internal cross-functional projects.
Collect and organize information.
Interact with other departments and functions within our global company.
Qualifications and experience:On-going Bachelor’s or Master’s studies in engineering or equivalent
Fluent English, both written and oral
Independent and organized, good attention to details
MS Office, word/excel, outlook
Desirable skillsDemonstrated collaboration skills
Interest or experience in medical device industry and regulatory affairs
Inclusion and DiversityGE 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 expression, age, disability, protected veteran status or other characteristics protected by law.
BehaviorsWe 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.
Total RewardsOur 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.
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Additional InformationRelocation Assistance Provided: No