Beschreibung

As an AI Documentation Leader in the Women's Health Ultrasound division, you will create essential regulatory documentation, collaborate with cross-functional teams, and ensure compliance for innovative ultrasound products. This role involves managing data activities and influencing future regulatory standards.

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

Benefits