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AI Documentation Leader(m/w/x)
Leading regulatory documentation for AI in medical devices, focusing on ultrasound product compliance, at medical technology innovator with 100+ years experience. Familiarity with V&V processes for medical devices and documentation practices essential. Free electric charging, birthday day off, complimentary company shuttle.
Requirements
- Bachelor’s degree and professional experience in Biomedical Engineering, Regulatory Affairs, Technical Writing or a related field
- Familiarity with V&V processes of medical devices and documentation practices
- Exceptional writing, editing, and proofreading skills
- Self-organized, disciplined, and reliable way of working
- High attention to detail and commitment to producing precise and compliant documentation
- Strong interpersonal and communication skills
- Fluency in both German and English language
Tasks
- Create and manage documentation for regulatory submissions
- Lead validation processes for ultrasound product compliance
- Support data-related activities for AI documentation
- Develop high-quality documentation per regulatory standards
- Maintain an overview of global regulatory requirements for AI in medical devices
- Drive advancements in AI and data infrastructure
- Participate in international forums to influence regulatory standards
- Support audits with notified bodies
- Collaborate with teams to ensure documentation adequacy
- Design verification plans and support clinical verification activities
- Communicate with data providers and negotiate contracts
- Drive internal review processes for contracts
- Facilitate supplier onboarding and payments
- Ensure compliant data collection with providers
- Track data quantities and review for completeness
- Manage data storage and retrieval with internal and external tools
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Benefits
Flexible Working
- Flextime and flexible working hours
Parking & Commuter Benefits
- Free electric charging stations
- Ample parking facilities
- Complimentary company shuttle
More Vacation Days
- Additional day off for birthday
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AI Documentation Leader(m/w/x)
Leading regulatory documentation for AI in medical devices, focusing on ultrasound product compliance, at medical technology innovator with 100+ years experience. Familiarity with V&V processes for medical devices and documentation practices essential. Free electric charging, birthday day off, complimentary company shuttle.
Requirements
- Bachelor’s degree and professional experience in Biomedical Engineering, Regulatory Affairs, Technical Writing or a related field
- Familiarity with V&V processes of medical devices and documentation practices
- Exceptional writing, editing, and proofreading skills
- Self-organized, disciplined, and reliable way of working
- High attention to detail and commitment to producing precise and compliant documentation
- Strong interpersonal and communication skills
- Fluency in both German and English language
Tasks
- Create and manage documentation for regulatory submissions
- Lead validation processes for ultrasound product compliance
- Support data-related activities for AI documentation
- Develop high-quality documentation per regulatory standards
- Maintain an overview of global regulatory requirements for AI in medical devices
- Drive advancements in AI and data infrastructure
- Participate in international forums to influence regulatory standards
- Support audits with notified bodies
- Collaborate with teams to ensure documentation adequacy
- Design verification plans and support clinical verification activities
- Communicate with data providers and negotiate contracts
- Drive internal review processes for contracts
- Facilitate supplier onboarding and payments
- Ensure compliant data collection with providers
- Track data quantities and review for completeness
- Manage data storage and retrieval with internal and external tools
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Benefits
Flexible Working
- Flextime and flexible working hours
Parking & Commuter Benefits
- Free electric charging stations
- Ample parking facilities
- Complimentary company shuttle
More Vacation Days
- Additional day off for birthday
About the Company
GE Healthcare
Industry
Healthcare
Description
Das Unternehmen ist ein global führender Innovator für Medizintechnik und digitale Lösungen mit mehr als 100 Jahren Erfahrung im Gesundheitswesen.
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