Design Assurance Manager (m/w/d)
Core
Responsible for Design Assurance of medical devices and software solutions, ensuring release compliance with quality and regulatory requirements (EU and FDA).
Role type
Design Assurance Manager
Builds
Medical devices and software solutions for emergency and intensive care
Domain
Medical Devices / Regulatory Compliance
Required skills
Regulatory knowledge (EU MDR, FDA), Software as a Medical Device (SaMD), Technical understanding, Analytical thinking, Audit management, Stakeholder communication
Preferred skills
Experience with US market/FDA, Risk minimization measures, Supplier agreement management
Technologies
MS Office
Responsibilities
Ensure Design Assurance for products and software solutions; Support regulatory questions especially for US market and FDA; Evaluate development projects and deliverables for process compliance; Analyze quality data and identify optimization potentials; Plan and conduct audits; Manage service providers and communicate with authorities
Seniority
Mid-Senior, hands-on IC