Quality Management & Regulatory Affairs Manager – Medical Devices (m/f/d)

As **Quality Management & Regulatory Affairs Manager (m/f/d)**, you ensure that our medical device portfolio meets the highest quality and regulatory standards. You are responsible for key QM processes for the companies of Avia Pharma Germany, keep us audit-ready at all times in line with ISO 13485 and MDR, and report directly to the Director of Scientific Affairs DACH. Your place of work is Wolfratshausen near Munich, full-time with the option to work remotely.

• *Your Responsibilities**
• Operational management of change control, complaint handling and CAPA for the companies of Avia Pharma Germany
• Preparation and execution of internal audits and ensuring continuous audit readiness in line with ISO 13485 and MDR
• Maintenance and further development of the quality management system, including support for the migration to an eQMS
• Qualified regulatory support for our medical device portfolio
• Contribution to the maintenance and updating of technical documentation
• Support with ongoing vigilance activities
• *Your Profile**
• University degree in a relevant scientific, technical, medical or pharmaceutical discipline
• At least one year of professional experience in regulatory affairs for medical devices
• At least one year of professional experience in quality management for medical devices, including experience in CAPA, change and complaint management