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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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Benefits
Flexibles Arbeiten
- Flextime and flexible working hours
Parkplatz & Pendelvorteile
- Free electric charging stations
- Ample parking facilities
- Complimentary company shuttle
Mehr Urlaubstage
- Additional day off for birthday
Noch nicht perfekt?
- GE HealthcareVollzeitnur vor OrtBerufserfahrenZipfab 55.000 / Jahr
- GE Healthcare
Lead Quality Specialist AI(m/w/x)
Vollzeitnur vor OrtSeniorZipfab 65.000 / Jahr - GE Healthcare
Regulatory Affairs Leader - Ultrasound Probes(m/w/x)
Vollzeitnur vor OrtBerufserfahrenZipf - GE Healthcare
Software Engineer(m/w/x)
Vollzeitnur vor OrtBerufserfahrenZipfab 60.000 / Jahr - GE Healthcare
Project Leader - Medical Software(m/w/x)
Vollzeitnur vor OrtBerufserfahrenZipfab 68.000 / Jahr
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Benefits
Flexibles Arbeiten
- Flextime and flexible working hours
Parkplatz & Pendelvorteile
- Free electric charging stations
- Ample parking facilities
- Complimentary company shuttle
Mehr Urlaubstage
- Additional day off for birthday
Über das Unternehmen
GE Healthcare
Branche
Healthcare
Beschreibung
Das Unternehmen ist ein global führender Innovator für Medizintechnik und digitale Lösungen mit mehr als 100 Jahren Erfahrung im Gesundheitswesen.
Noch nicht perfekt?
- GE Healthcare
Technical Writer / User Manual Specialist(m/w/x)
Vollzeitnur vor OrtBerufserfahrenZipfab 55.000 / Jahr - GE Healthcare
Lead Quality Specialist AI(m/w/x)
Vollzeitnur vor OrtSeniorZipfab 65.000 / Jahr - GE Healthcare
Regulatory Affairs Leader - Ultrasound Probes(m/w/x)
Vollzeitnur vor OrtBerufserfahrenZipf - GE Healthcare
Software Engineer(m/w/x)
Vollzeitnur vor OrtBerufserfahrenZipfab 60.000 / Jahr - GE Healthcare
Project Leader - Medical Software(m/w/x)
Vollzeitnur vor OrtBerufserfahrenZipfab 68.000 / Jahr