Head of Quality Regulatory Affairs/Management (Part-Time) (m/f/d)
Area of responsibility
In Quality Management and Regulatory Affairs, you will be responsible for the quality, safety and regulatory compliance of our medical technology products on the basis of an ISO 13485-certified QM system.
You are the driving force for sustainable quality work and regulatory compliance of class I - IIa medical devices
As a QMB, you fulfil the requirements of ISO13485 and strategically align quality management for continuous improvement and international product approvals and take responsibility for further certifications and product approvals.
As a Person Responsible for Regulatory Compliance (PRRC) in accordance with Article 15 of the Medical Devices Regulation MDR (2017/745), you ensure the regulatory compliance of our medical device.
You will work closely with our interdisciplinary team to bring about lasting change in the healthcare market together with us.
You are a team player - work and communicate in a solution orientated manner at the relevant interface between RA/QM and other departments such as development and production
Education: University degree in a medical, scientific, legal or technical field with at least 3 years of professional experience in the relevant field (preferably with expertise in neurorehabilitation).
Experience: You have relevant experience with the quality management system for medical devices (ISO 13485) and the European Medical Device Regulation (MDR). In addition, experience in software for medical devices according to IEC 62304 and in risk management (ISO 14971) is an advantage. Ideally, you already have experience as a QMB and PRRC.
Language skills: Very good German and good English skills.
Personality and way of working: You are characterised by analytical thinking and a very structured way of working. You are a team player and enjoy networking with interdisciplinary stakeholders. You are results-orientated and precise in the implementation of processes and documentation.