I have previously worked for small and mid-sized medical device companies in Product Development and Quality and Regulatory Affairs roles. Throughout my career I have contributed design activities of various products such as implants and cardiac and vascular products. Later, I have worked with Micro-Electronical-Mechanical Systems (MEMS) for medical devices and then made the move to the quality and regulatory field.
I am qualified as a medical device assessor and auditor for a Notified Body, where I gained practical experience in the following topics: Quality Management Systems (QMS) (ISO 13485), Risk Management (ISO 14971), Software (IEC 62304), Usability (ISO 62344), Information Security (ISO 27001) and on Management Review and Clinical Evaluation.
Additionally, my skills include building a QMS, including drafting the procedures from scratch in my last position, creation of a ‘culture of quality’ and performing relevant trainings including stakeholder management for the whole organization.
At Starodub, I would like to use my experience and provide clients with the best and most efficient science-based support. Furthermore, I am proud to be a part of the multidisciplinary team contributing to overall positive impact at our customers.