Experte Risikomanag. & Validierung – KI-basierte SaMD (Software as a Medical Device) (w/m/d) remote
Randstad Professional GmbH (vorm. GULP)
Contact person: Sebastian Burkhardt
München, Germany
Description
Unser Kunde, ein Medizintechnik-Forschungsunternehmen, sucht externe Unterstützung durch einen Risk Management & Validation Lead (w/m/d) im Bereich AI SaMD (AI-basierte Software as a Medical Device).
Der Einsatz kann zu einem Großteil Remote erfolgen - es wird zudem zu sporadischen Terminen vor Ort in München kommen.
Eine Auslastung von mind. 2 Tagen/Woche wird als Minimum voraus gesetzt - gerne ist auch eine höhere Auslastung von bis zu 100% denkbar.
Experience:
8+ years in Medical Device Software, Quality, Validation, or Regulatory
Compliance, with 3+ years in AI/ML-enabled healthcare solutions.
Key Responsibilities
- Lead risk management activities for AI SaMD products in compliance with ISO
14971.
- Define and oversee verification and validation strategies for AI/ML-based medical
software.
- Ensure compliance with IEC 62304, ISO 13485, FDA SaMD guidance, EU
MDR, and GMLP requirements.
- Evaluate AI-specific risks, including model performance, bias, cybersecurity, data
integrity, and model drift.
- Support regulatory submissions, audits, and post-market surveillance activities.
- Collaborate with Engineering, Data Science, Clinical, Quality, and Regulatory
teams to ensure safe and compliant product releases.
Required Skills
- AI/ML Risk Management
- Software Verification & Validation (V&V)
- Medical Device Regulatory Compliance
- Requirements Traceability
- Cybersecurity & Quality Management Systems
- Stakeholder Management and Cross-functional Leadership
Ideal Candidate:
A seasoned medical device professional with strong expertise in AI/ML
validation, risk management, and regulatory compliance, capable of driving safe,
effective, and audit-ready AI SaMD solutions.