Anna-Karin Andermo is a senior regulatory affairs consultant at Key2Compliance AB. She has worked at several small to medium sized medical device companies, both as a consultant and as a QA/RA manager.
As a Regulatory Affairs manager at a medical device manufacturing company with products sold worldwide, Anna-Karin was responsible for the regulatory compliance of devices ranging from class I to III, including sterile devices. Apart from maintaining Technical files and taking lead in CE marking projects, she has also submitted regulatory applications to several countries, for example USA, Canada, Australia and China.
As a Quality Assurance manager, she was responsible for maintaining a Quality management system according to ISO 13485 and FDA QSR.
Other assignments have included being risk manager in several product development projects, implementing a system for UDI, internal auditing and drawing up regulatory strategies.