Software Risikomanag. & Validierung – KI-basierte SaMD - remote

Unser Kunde, ein Medizintechnik-Forschungsunternehmen, sucht externe Unterstützung durch einen Software 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.

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.

Experience

8+ years in Medical Device Software, Quality, Validation, or Regulatory Compliance, with 3+ years in AI/ML-enabled healthcare solutions.

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 Software solutions.