Senior Quality Management and Regulatory Affairs Manager(m/w/x)

Description

In this role, you will guide regulatory and quality requirements for software projects, create essential documentation, and enhance the Quality Management System. Your efforts will help foster a culture of quality and compliance while keeping pace with regulatory changes.

Requirements

• •Master’s degree in Engineering, Computer Science, or related field
• •Excellent understanding of software development processes and documentation requirements
• •Knowledge of technical principles of AI models and software cyber-security
• •Proven industry experience in quality management and regulatory affairs in med-tech software
• •Strong knowledge of ISO 13485, IEC 62304, MDR, and FDA regulations for med-tech software
• •Strong organizational, analytical, and communication skills
• •Ability to manage multiple projects and deadlines effectively
• •Excellent problem-solving skills and attention to detail
• •Willingness to continuously learn and extend skills in technical and regulatory domains
• •Hands-on software development experience (optional)

Tasks

• •Provide guidance on regulatory and quality requirements for software projects
• •Create technical documentation for industry projects with software development teams
• •Support MDR and FDA conformant documentation for medical AI models
• •Maintain and improve the Quality Management System in alignment with ISO 13485
• •Develop, implement, and monitor quality policies, procedures, and KPIs
• •Coordinate internal audits and prepare for external audits
• •Monitor regulatory changes and assess their impact on processes and products
• •Promote a culture of quality and compliance across the organization
• •Explore opportunities for growth into a team lead role

Benefits