As AI Documentation Leader, you will be responsible for creating and managing documentation essential for regulatory submissions to agencies, supporting the approval and compliance of ultrasound products designed for women's health
Job Summary
As AI Documentation Leader, you will be responsible for creating and managing documentation essential for regulatory submissions to agencies, supporting the approval and compliance of ultrasound products designed for women's health.
The role offers an exciting and diverse range of responsibilities in a growth-oriented company with an interdisciplinary team and an international work environment.
GE HealthCare provides flextime, flexible working hours, free electric charging stations, ample parking, an additional day off for your birthday, and convenient public transportation access with a company shuttle.
Matching Summary
As AI Documentation Leader, you will be responsible for creating and managing documentation essential for regulatory submissions to agencies, supporting the approval and compliance of ultrasound products designed for women's health.
Salary
Base: €70,000 starting annual compensation; Bonus/Equity: Not specified; Benefits: Competitive salary and fringe benefits reflecting profile and experience
Skills & Requirements
Must-have
Regulatory documentation for AI medical devices
Data analysis and curation for AI documentation
Collaboration with cross-functional teams
Knowledge of global regulatory requirements
Validation and verification process support
Nice-to-have
Strong interpersonal and communication skills
Self-organized and disciplined work style
Fluent English with German as a plus
Experience with biomedical engineering or regulatory affairs
Passion for precise and compliant documentation
Key Requirements
Bachelor’s degree in Biomedical Engineering or related field
Professional experience in regulatory affairs or technical writing