Regulatory Medical Documentation Specialist

GE HealthCare; Vöcklamarkt; On-site; EUR 50,000 - 62,000; Full time

Benefits offered by this job

Competitive salary

Flextime

Electric charging stations

Ample parking

Birthday day off

Company shuttle

International work environment

Job summary

GE HealthCare seeks a Clinical Documentation Specialist in Austria's Women's Health Ultrasound division to create, compile, and manage regulatory documentation for submissions and audits. You will collaborate with regulatory affairs, QA, engineering and clinical teams to ensure accuracy, clarity and compliance, with strong writing in German and English.

The role offers flextime, relocation considerations, and a competitive starting salary of €56,000 per year, plus a comprehensive benefits

Qualifications

• Graduation of high school or bachelor’s degree in Technical Writing, English, Biomedical Engineering, Regulatory Affairs, or a related field.

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.

Skills

Writing

Editing

Proofreading

Communication

Time management

Education

High school or bachelor’s degree in Technical Writing/English/Biomedical Engineering/Regulatory Affairs

Tools

Microsoft 365

Job description

GE HealthCare seeks a Clinical Documentation Specialist in Austria's Women's Health Ultrasound division to create, compile, and manage regulatory documentation for submissions and audits. You will collaborate with regulatory affairs, QA, engineering and clinical teams to ensure accuracy, clarity and compliance, with strong writing in German and English.

The role offers flextime, relocation considerations, and a competitive starting salary of €56,000 per year, plus a comprehensive benefits