QA/RA – Manager (SaMD)
Tasks:
· Responsibility for international approvals/registrations of our software and medical devices including the coordination of the preparation and compilation of the required documents.
· Assessment of the conformity of the documentation with the applicable regulations
· Independent implementation and maintenance of the associated product authorizations/registrations
· Assuming responsibility for a group of non-EU countries regarding the transfer of regulatory requirements to the company
· Communication with customers, approval authorities and notified bodies.
· Internal contact person (m/f/d) for regulatory issues; interface to development, product management, IT service and quality management IT service and quality management
· Maintenance of software life cycle processes according to IEC 62304 processes, creation of templates for development documentation
· Assumption of responsibility as quality management representative (QMB) and maintenance of the quality management system (QMS) in accordance with ISO 13485
· Review and release of approval-relevant documentation
Profile:
· Successfully completed technical studies (e.g. medical technology or biomedical engineering); alternatively, successfully completed vocational training with further training in regulatory affairs and quality management.
· Professional experience in regulatory affairs (medical technology) and quality management or in a comparable position in a regulated environment
· Experience with software as a medical device or healthcare software
· Strong knowledge in dealing with national and international standards and regulations relevant to medical devices, as well as knowledge of Regulation.
· 2017/745 EU (MDR) and ideally in the relevant medical device standards (IEC 60601- 1, ISO 14971, IEC 62304) such as EN ISO 13485:2016,
· Affinity for creating approval-relevant documents.
· Technical understanding
· Very good written and spoken English skills.