Regulatory Affairs Engineering Lead, AI/ML
Tasks
- Assess regulatory impact of software and AI ML model changes
- Coordinate notified body and agency reviews
- Deliver regulatory training for process owners and product teams
- Develop regulatory strategy for AI ML SaMD
- Integrate EU AI Act obligations into development workflows
- Integrate IEC 62304 into software development workflows
- Manage change control activities
- Monitor incidents and provide feedback into product development
- Prepare regulatory submissions and technical files
- Provide input to regulatory and compliance matters
- Support internal and external audits
- Support post-market surveillance
Perks/Benefits
Skills/Tech-stack
21 CFR part 820 | 81001-5-1 | AI Act | CFR Part 820 | EU AI | EU AI Act | EU MDR | FDA 21 CFR | FDA 21 CFR Part 820 | IEC 14971 | IEC 62304 | IEC 81001 | IEC 81001-5 | IEC 81001-5-1 | IEC 82304 | IEC 82304-1 | ISO 13485 | ISO 14971 | Part 820 | Qms | UK MDR
Education
Bachelor of Engineering | Bachelor of Science | Master of Science
Regions
Countries
States
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