Job Description Summary

As Clinical Documentation Specialist (f/m/d) in the Women's Health Ultrasound division, you will be responsible for creating, compiling, and managing documentation essential for regulatory submissions to agencies. Furthermore, your role will be leading the validation process, supporting the successful approval and compliance of ultrasound products designed for women's health.

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

Key Responsibilities:

• Regulatory Documentation: Develop, write, and edit high-quality documentation required for regulatory submissions. Additionally supporting function during audits facing notified bodies.
• V&V Activities: Document validation processes, including protocols, test plans, test cases, and test reports. Ensure that all V&V activities are accurately captured and reported.
• Review and Editing: Conduct thorough reviews and edits of documents to ensure accuracy, clarity, and consistency.
• Collaboration: Work closely with regulatory affairs, quality assurance, engineering, clinical, and V&V teams to gather necessary information and ensure documentation accuracy and completeness.
• Feedback Incorporation: Collect and incorporate feedback from internal teams and regulatory bodies to continuously improve documentation quality.

Qualifications:

• Graduation of high school or bachelor’s degree in Technical Writing, English, Biomedical Engineering, Regulatory Affairs, or a related field.
• Background in office-based work environment (Microsoft 365). 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 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 € 56.000. 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

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

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Additional Information