Base: € 70,000 (minimum); bonus/equity: not specif...
Hybrid
Ai documentation for regulatory submissions
Medical device regulatory requirements
Data analysis and curation for ai
You will be responsible for creating and managing documentation essential for regulatory submissions to agencies, enabling the successful approval and compliance of ultrasound products designed for women's health
Job Summary
You will be responsible for creating and managing documentation essential for regulatory submissions to agencies, enabling the successful approval and compliance of ultrasound products designed for women's health.
Key responsibilities include developing, writing, and editing high-quality documentation according to regulatory standards, maintaining an overview of global regulatory requirements for AI in medical devices, and supporting audits.
GE HealthCare offers a role-specific compensation and a competitive salary and fringe benefit package, with a minimum annual compensation package starting at € 70,000 in Austria.
Matching Summary
You will be responsible for creating and managing documentation essential for regulatory submissions to agencies, enabling the successful approval and compliance of ultrasound products designed for women's health.
Salary
Base: € 70,000 (minimum); Bonus/Equity: Not specified; Benefits: Competitive salary and fringe benefit package
Skills & Requirements
Must-have
AI documentation for regulatory submissions
Medical device regulatory requirements
Data analysis and curation for AI
Writing and editing technical documentation
Collaboration with cross-functional teams
Nice-to-have
Interpersonal and communication skills
Self-organized and disciplined
High attention to detail
Passion for working with documents
German language proficiency
Key Requirements
Bachelor’s degree in relevant field
Professional experience in Biomedical Engineering, Regulatory Affairs, or Technical Writing