Part time job that you can continue with your existing job. We keep your details anonymous. 100% remote working
Knowledge of Implementing quality management system and regulatory strategies for maintaining compliance with established standards like ISO 13485, ISO 14971, US FDA and CE Marking.
Responsible for implementation of EU MDR related deliverables across product lines.
Actively participating in GAP analysis between MDD and MDR thereby identifying gaps in the current devices
Prepare regulatory documents and responses to regulatory authorities, specifically working on Clinical Evaluation Reports (CERs)
Combine understanding of scientific and research methodology, medical device regulations and guidelines, and product knowledge, to support Regulatory Affairs submissions for CE Marking of new devices and maintaining of CE Mark for existing devices in accordance with MEDDEV 2.7/1 Rev 4, MDD, AIMDD, and EU MDR 2017/745.