Regulatory Docs Specialist - Medical Devices (V&V)

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

Benefits offered by this job

Flextime

Free parking

Birthday day off

Company shuttle

Job summary

GE HealthCare seeks a Clinical Documentation Specialist (f/m/d) in Austria to create and manage regulatory documentation for ultrasound products focused on women’s health. The role leads validation processes and ensures compliance for regulatory submissions.

You will collaborate with regulatory affairs, QA, engineering, and clinical teams, drafting precise, clear documentation in both German and English, and supporting audits with attention to detail and reliability.

Qualifications

• Bachelor’s degree in Technical Writing, English, Biomedical Engineering, Regulatory Affairs, or related field.
• Experience in office-based environment; familiarity with V&V processes of medical devices is a plus.
• Exceptional writing, editing, proofreading, and ability to convey complex regulatory information clearly.
• Self-organised, disciplined and reliable with good time management.
• High attention to detail and commitment to producing precise, compliant documentation.
• Strong interpersonal and communication skills for cross-functional collaboration.
• Proficiency in German and English writing and communication.

Responsibilities

• Regulatory Documentation: develop, write, and edit high-quality documentation for regulatory submissions and audits.
• V&V Activities: document validation protocols, test plans, cases and reports.
• Reviewing and editing documents for accuracy, clarity and consistency.
• Collaborating with regulatory affairs, QA, engineering, clinical and V&V teams to gather information.
• Incorporating feedback from internal teams and regulatory bodies to improve docs.

Skills

Writing

Editing

Proofreading

Communication

Time management

Attention to detail

Education

Bachelor's degree or equivalent in Technical Writing/Regulatory Affairs/Biomedical Engineering/English

Tools

Microsoft 365

Job description

GE HealthCare seeks a Clinical Documentation Specialist (f/m/d) in Austria to create and manage regulatory documentation for ultrasound products focused on women’s health. The role leads validation processes and ensures compliance for regulatory submissions.

You will collaborate with regulatory affairs, QA, engineering, and clinical teams, drafting precise, clear documentation in both German and English, and supporting audits with attention to detail and reliability.