Manager in Quality Management & Regulatory Affairs (m/f/d) - Remote

Overview

We are looking for a Manager in Quality Management & Regulatory Affairs to help shape the future of the healthcare industry with innovative digital health solutions.

In Short

• Responsible for regulatory tasks in quality management, medical devices, data protection, and information security.
• Work closely with implementation teams to ensure compliance of products.
• Continuously develop the Quality Management System (QMS) to meet regulatory requirements.
• Update processes and maintain necessary documentation for compliance.
• Plan, coordinate, and conduct internal and external audits.
• Support management reviews to identify weaknesses in the QMS.
• Stay updated on new legal requirements in digital health.
• Conduct training for employees on regulatory topics.

Requirements

• Degree in a scientific or technical field or equivalent qualification.
• Several years of experience in quality management and regulation in medical devices.
• Solid knowledge of ISO 13485 / IEC 62304 standards.
• Experience with ISO 27001 or other information security standards is a plus.
• Experience in conducting audits and certifications.
• Structured, analytical working style with strong documentation skills.
• Team player comfortable in interdisciplinary environments.
• Ability to communicate complex issues clearly in German and English.
• Self-motivated and proactive in driving projects forward.

Benefits

• Modern working environment with flexible location within Germany (100% Remote).
• Flexible working hours.
• Flat hierarchies with short decision-making processes.
• Opportunities to use the latest and innovative technologies.
• Continuous development of personal and professional skills.
• Company pension scheme, private health insurance, and bike leasing.
• Fresh fruit, muesli bar, free drinks, and regular company events.