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, particularly for the US market and FDA.
Role type
Design Assurance Manager
Builds
Innovative high-end medical devices for emergency and intensive care
Domain
Medical Devices / Regulatory Compliance
Required skills
Regulatory knowledge (EU MDR, FDA), Software as a Medical Device (SaMD) requirements, Technical understanding, Analytical thinking, Audit planning and execution, Stakeholder management, Contract negotiation
Preferred skills
Experience with US market FDA requirements, Risk minimization analysis
Technologies
MS Office
Responsibilities
Ensure product and software release compliance with quality and regulatory standards; Support regulatory inquiries especially for US market and FDA; Evaluate development projects and deliverables against defined processes; Analyze quality data and identify optimization potentials; Plan and conduct audits to ensure legal and normative compliance; Manage service providers and communicate with authorities; Create and review quality and supplier agreements