Senior Consultant – CRA & AI Act Pharma & MedTech
Core
Lead and execute GAP analyses against CRA and AI Act for connected medical devices and digital pharmaceutical solutions; support customers in classifying AI systems under the AI Act; develop and review regulatory, risk, and cybersecurity processes throughout the product lifecycle.
Role type
Senior Consultant (Regulatory & Cybersecurity Strategy)
Builds
Regulatory compliance strategies and cybersecurity processes for pharma and medtech clients
Domain
Healthcare (Pharma & MedTech) + Cybersecurity + AI Regulation
Deliverable
production ML models
Required skills
GAP analysis, AI Act classification, regulatory documentation, risk management, cybersecurity processes, software lifecycle standards (IEC 62304/81001-5-1), AI/ML governance, ISO 14971, GAMP 5, MDR/IVDR, GxP
Preferred skills
Cyber Resilience Act (CRA) experience, RA (requirements analysis), data governance, explainability, human oversight
Technologies
AI Act, CRA, MDR, IVDR, IEC 62304, IEC 81001-5-1, ISO 14971, GAMP 5, GxP, 21 CFR 820, ISO 13485
Responsibilities
Lead GAP analyses for CRA and AI Act; Support AI system classification; Develop regulatory and cybersecurity processes; Bridge quality/regulatory and technical cybersecurity expertise; Shape Knightec's service offering
Seniority
Senior, hands-on IC
