Natalya Koshnitsky has served as the Director of Quality Systems and Regulatory Affairs where she successfully designed and implemented a global quality management system and obtained an umbrella ISO 13485 certification for three facilities in the US and Central America. She is highly experienced in all areas of quality management system and compliance, including but not limited to CAPA, Internal non-conformance, internal and supplier auditing, supplier control and post market surveillance.
By working with her regulatory partners, Natalya has successfully commercialized medical device products in over 42 countries worldwide, including CE Marking and 510(K) clearance.
Natalya is an authentic leader with a natural ability to connect with various stakeholders of the organization to reach the set objectives and drive business forward.
