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QA/RA Manager (SaMD - Fully Remote)

Job Description

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.