Regulatory Affairs Manager / Quality Officer (m/f/d) (Technician - Medical Technology/Bachelor Professional in Technology)

ELCON Medical Instruments GmbH from Tuttlingen has been developing and distributing surgical instruments and endoscopic devices for clinics and specialist retailers worldwide since 1977. As an owner-managed company with flat hierarchies and a genuine sense of togetherness, we attach great importance to a warm working atmosphere and the soft skills of our employees. We are looking for you to strengthen our team in Quality Management / Regulatory Affairs.

Your Tasks

• Maintenance and strategic further development of our quality management system according to DIN EN ISO 13485
• Implementation of applicable legal and regulatory requirements, including Regulation (EU) 2017/745 (MDR)
• Independent planning, implementation, and monitoring of international approvals in cooperation with our local representatives
• Creation and maintenance of the Technical Documentation of our medical devices
• Preparation and support of internal as well as external audits
• Risk management as well as complaint and change management
• Support and implementation of validations as well as their maintenance
• Trend analyses and participation in management reviews
• Creation of new articles and implementation of quality-relevant processes
• Communication with external bodies, e.g., Notified Body and Regierungspräsidium
• Support of the transition to SAP Business One

Your Profile

• Completed studies in Medical Technology or a comparable technical training
• Several years of professional experience in the field of Regulatory Affairs / Quality Management in medical technology
• Sound knowledge of Regulation (EU) 2017/745, DIN EN ISO 13485, MDR and other relevant standards
• Experience with international approval processes
• Sound knowledge in technical documentation for medical devices
• Confident handling of MS Office; experience with Majesty/SAP Business One is an advantage
• Very good English skills in speaking and writing
• Strong analytical thinking skills as well as the ability to communicate complex issues understandably in interdisciplinary teams

What We Offer You

• A responsible area of activity with great individual responsibility in an owner-managed company
• Flat hierarchies, short decision-making paths, and a collegial sense of togetherness
• Working in a young, dynamic, and flexible team
• Flexible working hours