Senior Consultant – CRA & AI Act Pharma & MedTech
Core
Lead GAP analyses and support customers in classifying AI systems and connected medical devices against the EU Cyber Resilience Act (CRA) and AI Act.
Role type
Senior Consultant (Regulatory Compliance & Cybersecurity)
Builds
Regulatory documentation, risk and cybersecurity processes for connected medical devices and digital pharmaceutical solutions
Domain
Pharma & MedTech, EU Regulatory Compliance, Cybersecurity
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure
Required skills
GAP analysis, AI system classification, regulatory documentation, risk management, cybersecurity processes, requirements management, AI/ML lifecycle understanding, ISO 14971, GAMP 5
Preferred skills
CRA and AI Act expertise, MDR/IVDR, ISO 13485, GxP, 21 CFR 820, IEC 62304, IEC 81001-5-1, data governance, explainability, human oversight
Technologies
MDR, IVDR, CRA, AI Act, ISO 13485, GxP, 21 CFR 820, IEC 62304, IEC 81001-5-1, ISO 14971, GAMP 5
Responsibilities
Lead GAP analyses against CRA and AI Act for connected medical devices and digital pharmaceutical solutions; Support customers in classifying AI systems according to the AI Act; Develop and review regulatory documentation, risk and cybersecurity processes throughout the product lifecycle; Bridge quality/regulatory and technical cybersecurity expertise in customer organizations; Shape Knightec Group's service offering in this area
Seniority
Senior, hands-on IC
