Projektleiter:in Regulatory Affairs – Medizinsoftware
Core
Leading cross-functional projects to achieve MDR certification for medical software, ensuring documentation integrity and aligning regulatory compliance with agile development.
Role type
Senior Project Manager (Regulatory Affairs)
Builds
Certified medical software products for clinical practice
Domain
Medical device regulation (MDR) and software development
Required skills
MDR certification, project management, cross-functional team leadership, documentation management, risk management, budgeting, stakeholder communication
Preferred skills
ISO 9001/13485/27001, software development lifecycle, audits, AI tools
Technologies
MDR, ISO 9001, ISO 13485, ISO 27001
Responsibilities
Coordinate cross-functional teams (development, product, quality, partners) for certification projects; Manage MDR certification milestones, dependencies, and risks; Maintain certification documentation and evidence; Align regulatory processes with agile software development; Report to executive leadership on schedules, resources, and budget; Facilitate communication between regulatory and development teams
Seniority
Senior, hands-on IC