Job Description Summary
As AI Documentation Leader (f/m/d) in the Women's Health Ultrasound division, you will be responsible for creating and managing documentation essential for regulatory submissions to agencies. Your contributions will enable the successful approval and compliance of ultrasound products designed for women's health and will span from maintaining an overview of regional regulatory requirements to data‑related activities for AI documentation, including analysis, curation, evaluation, and clean‑up.
At GE HealthCare, our machines, our software, our solutions, our services, and our people make a genuine difference to medical professionals and patients all over the world. That’s because we never lose sight of what healthcare really needs—the human touch.
Job Description
Job Summary
As AI Documentation Leader (f/m/d) in the Women's Health Ultrasound division, you will be:
* working closely with the Data Science team, with data scientists, analytics engineers, and cross‑functional experts;
* responsible for creating, compiling, and managing documentation essential for regulatory submissions to agencies;
* leading validation processes, supporting the successful approval and compliance of ultrasound products designed for women's health;
* supporting data‑related activities for AI development and documentation, including analysis, curation, annotation, and clean‑up.
Key Responsibilities
* Regulatory Documentation:
o Develop, write, and edit high‑quality documentation according to regulatory standards to achieve clearance for AI products in medical devices;
o Maintain an overview of regulatory requirements for AI in medical devices across global regions;
o Drive advancement of AI and data infrastructure to keep up with latest regulatory requirements;
o Participate in international, cross‑industry forums to understand and influence future regulatory requirements and standards;
o Support during audits facing notified bodies;
o Collaborate with cross‑functional teams to gather necessary information and ensure regulatory documentation adequacy;
o Design verification plans and strategies and support clinical verification activities for regulatory documentation.
* Data Collection:
o Communicate with prospective data providers and negotiate contractual terms;
o Drive internal review and clearance processes for contracts;
o Handle internal tools to facilitate timely supplier onboarding, collaboration, and payments;
o Communicate with data providers to ensure compliant and protocol adherent data collection;
o Track received data quantities and facilitate the review of incoming data for completeness and clinical adequacy;
o Work with internal and external tools targeted at data management ensuring structured and format consistent data storage and retrieval.
Qualifications
* Bachelor’s degree and professional experience in Biomedical Engineering, Regulatory Affairs, Technical Writing or a related field;
* Familiarity with V&V processes of medical devices and documentation practices appreciated;
* Exceptional writing, editing, and proofreading skills. Ability to interpret and convey complex technical and regulatory information clearly;
* Self‑organized, disciplined and reliable way of working. Needs to manage their own time effectively and set their own goals;
* High attention to detail and commitment to producing precise and compliant documentation. Passion and dedication in working with files and documents;
* Communication: Strong interpersonal and communication skills to effectively collaborate with cross‑functional teams and regulatory authorities;
* Ability to communicate and write fluent in both German and English language.
What We Offer
* We offer a role specific compensation and a competitive salary and fringe benefit package reflecting your profile and experience;
* In Austria we are required to state the minimum pay. For this position, the annual compensation package starts at € 70.000. We will be pleased to discuss the appropriate effective salary based on your qualifications and experience;
* An exciting and diverse range of responsibilities in a growth‑oriented company;
* An interdisciplinary team and an international work environment;
* Flextime and flexible working hours;
* Free electric charging stations and ample parking facilities on the company premises;
* An additional day off for your birthday;
* Convenient public transportation access with a complimentary company shuttle to the Redl‑Zipf train station, located 2 km away.
If you are interested in learning more we are looking forward to your online‑application!
Don't meet all the requirements? We are aware that there is almost never a perfect profile. You can learn (almost) anything as long as you are interested and enjoy new topics and challenges. In short: we look forward to receiving your application, even if you do not yet meet the requirements 100%!
About Us
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.
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.
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 expression, age, disability, protected veteran status or other characteristics protected by law.
GE HealthCare – Creating a world where healthcare has no limits
Additional Information
Relocation Assistance Provided: Yes
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