Project Manager

Project Manager - Quality Management System for Medical Information Systems Role Description The mission is to establish and further develop a comprehensive quality management system that ensures compliance and governance for medical information systems. You will lead mapping, strategy, process design, and implementation in an environment with multiple stakeholders and ongoing initiatives. Work Tasks • Conduct current state mapping of organization, projects, and collaboration partners. • Develop strategy and quality management system according to applicable regulations. • Define processes for governance, management, development, administration, and roles/responsibilities. • Establish structure for technical documentation and templates based on existing documentation. • Coordinate relevant stakeholders for common working methods and broad anchoring. • Ensure the system supports development, governance, and lifecycle management in line with legal requirements and business needs. Requirements • Excellent Swedish, both spoken and written. • Experience in the last five years of producing and structuring technical documentation for medical technology software or information systems. • At least 5 years of confirmed experience developing and implementing quality management systems for Medical Technology Products or medical information systems according to regulations such as MDR/IVDR or HSLF-FS 2022:42, verified by two relevant reference assignments completed in the last three years. • Documented knowledge and experience with processes for governance, management, development, and lifecycle management of medical technology software or medical information systems. • Ability to analyze complex information and communicate conclusions adapted to different target groups. • Self-driven with documented delivery capability in larger healthcare organizations, including responsibility for QMS, processes, or technical documentation related to software classified as Medical Technology Product or medical information system. Meriting Factors • Management and structuring of management systems according to ISO 13485. • Good knowledge of IEC 62304 and ISO 14971. • Experience of collaboration between larger organizations, academia, and national actors in digital/technical development projects. Start/Duration • Start: 2026-01-12 • Duration: until 2026-03-31 (possibility of extension, 6 months) • Scope: 100% Location Gothenburg About Rasulson Consulting Rasulson Consulting is a specialized staffing and recruitment company in the IT sector. We collaborate with both established technology companies and innovative startups to offer attractive career opportunities for those who want to develop within digitalization and IT. Through our deep technical expertise and extensive network, we match the right consultant with the right assignment – quickly and accurately. With us, you receive personal advice, continuous feedback, and the opportunity to take the next step in your career.