Regulatory Affairs Leader – AI Software Devices
Location
Germany
Posted
1 day ago
Salary
0
Seniority
Senior
Job Description
Regulatory Affairs Leader – AI Software Devices
GE HealthCare
• Provide regulatory leadership and strategic direction for Ultrasound regulatory AI Software programs • Support compliance of premarket submissions/registrations and post market compliance • Develop regulatory strategies to help optimize regulatory submission pathways • Utilize technical expertise and judgement to solve problems • Assess changes in existing products and determine the need for new / revised licenses or registrations • Review and approve advertising and promotion material to ensure consistency with approved claims and regulatory requirements • Contribute to writing and editing technical documents • Research, analyze, integrate and organize background information from diverse sources for regulatory submissions • Apply regulatory requirements and understand their impacts on submissions and pre- and post-market compliance.
Job Requirements
- Proven experience working in a regulated field, especially AI software
- Advanced practical experience in the Quality & Regulatory Affairs
- Bachelor's degree in software engineering, regulatory affairs or equivalent
- Strong oral and written communication skills
- Demonstrated ability to analyze and resolve problems
- Ability to document, plan, market, and execute programs
- Established project management skills
- Strong communication skills in English (both written and oral).
Benefits
- Inclusion and diversity
- Equal Opportunity Employer
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