Senior Consultant (m/w/d) Regulatory Affairs für Medizinprodukte, Software und KI
Core
Senior Regulatory Affairs Consultant supporting manufacturers in developing safe medical devices, meeting regulatory requirements, and launching innovations internationally via consulting, digital tools, and seminars.
Role type
Senior IC Regulatory Affairs Consultant (Medical Devices, Software, AI)
Builds
Regulatory approval strategies and dossiers for medical devices and Software as a Medical Device (SaMD/SiMD) including AI functions
Domain
Medical Devices / Software / Artificial Intelligence / Regulatory Affairs
Required skills
Regulatory strategy development, MDR/FDA compliance, Technical documentation, Product classification, Stakeholder communication, ISO 13485/14971/IEC 62304 standards knowledge, Software regulation understanding, AI regulatory assessment
Preferred skills
International market knowledge (beyond EU/USA), German and English fluency
Technologies
MDR, FDA, ISO 13485, ISO 14971, IEC 62304
Responsibilities
Develop regulatory approval strategies for EU, USA, and international markets; Support device and SaMD/AI product approvals; Translate regulatory requirements into actionable steps; Create and review technical documentation and submission dossiers; Evaluate products and technologies for qualification and classification; Communicate with authorities and stakeholders
Seniority
Senior, hands-on IC