Regulatory Documentation Specialist, Medical Devices (Flexible Hours)

MS0017 GE Healthcare Austria GmbH & Co OG; Zipf; On-site; EUR 50,000 - 62,000; Full time

Benefits offered by this job

Growth opportunities

Interdisciplinary team

Flextime

Charging stations

Birthday day off

Company shuttle to train station

Job summary

GE HealthCare is seeking a Clinical Documentation Specialist (f/m/d) in the Women’s Health Ultrasound division in Austria. You will create, compile, and manage documentation for regulatory submissions and lead validation processes to ensure compliance of ultrasound products aimed at women’s health.

You will collaborate with regulatory affairs, QA, engineering, clinical, and V&V teams, ensuring accuracy and completeness of documents, while maintaining strong German and English writing skills and

Qualifications

• Bachelor’s degree in Technical Writing, English, Biomedical Engineering, Regulatory Affairs, or related field.
• Experience in an office-based environment (Microsoft 365).
• Familiarity with V&V processes of medical devices and documentation practices.
• Exceptional writing, editing, and proofreading skills.
• Ability to interpret and convey complex technical and regulatory information clearly.
• Self-organization, discipline, and reliability in work planning.

Responsibilities

• Regulatory Documentation: Develop, write, and edit high-quality documentation for regulatory submissions; support audits.
• V&V Activities: Document validation processes, protocols, test plans, test cases, and test reports.
• Review and Editing: Conduct thorough reviews of documents for accuracy and clarity.
• Collaboration: Work with regulatory affairs, QA, engineering, clinical, and V&V teams.
• Feedback Incorporation: Integrate feedback from internal teams and regulatory bodies to improve quality.

Skills

Technical writing

Editing

Documentation

Microsoft 365

German & English bilingual

Cross-functional collaboration

Time management

Attention to detail

Education

Bachelor’s degree in Technical Writing or related field

High school diploma

Tools

Microsoft 365

Job description

GE HealthCare is seeking a Clinical Documentation Specialist (f/m/d) in the Women’s Health Ultrasound division in Austria. You will create, compile, and manage documentation for regulatory submissions and lead validation processes to ensure compliance of ultrasound products aimed at women’s health.

You will collaborate with regulatory affairs, QA, engineering, clinical, and V&V teams, ensuring accuracy and completeness of documents, while maintaining strong German and English writing skills and