Required skills
- Risk Management
- Software Validation
- Regulatory Compliance
- AI/ML Healthcare
- ISO 14971
- IEC 62304
- EU MDR
- FDA Requirements
- ISO 13485
- FDA SaMD Guidance
- GMLP
Languages: German
Job description
Experienced expert sought for risk management, validation, and regulatory compliance of AI-based medical software.
Project overview
Software Risk Management & Validation Lead – AI-based Medical Software
Software Validation Lead – AI-based Medical Software
Wanted: Experienced expert for risk management, validation, and regulatory compliance of AI-based medical software.
Expectations:
Framework: Start 11/16/2026, permanent, predominantly remote with occasional appointments in Munich.
- ISO 14971, IEC 62304, EU MDR and FDA requirements
- Three years in the AI/ML healthcare sector.
- IEC 62304, ISO 13485, FDA SaMD guidance, EU
- MDR, and GMLP.
Project details
- Start: ab sofort
- Duration: 12 Monate
- Remote: remote
- Location: Muenchen, Deutschland, DE
- Rate: 120-120 EUR/h
- Languages: German
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