Hello everyone, I am Hyun-Woo. I have been working in the medical device industry and there in the field of regulatory affairs and quality management for more than eight years. I got into this field by chance when I was looking for a job in Germany after my return from East Asia where I worked in the field of intercultural relations for three years. Regulatory Affairs (RA) and Quality Management (QM) are very essential aspects within a company in my view although there is hardly any awareness in public. A good RA/QM system does not only guarantee the success of a company, it also ensures the safety and efficacy of medical devices while reducing the risks as much as possible. So every party involved benefits from this system, from the manufacturer to the user and the patient. And on top it ensures compliance. These aspects have always motivated me to stay in this field as I am convinced that you can make a positive contribution. Although I am specialized in medical devices, RA/QM exists in many other areas such and there are parallels. Furhtermore, I realized that my experience in working and living in different cultures is a big contribution to my work. I am very happy to share my experience with anyone who is interested in this field. I also think exchanging thoughts on this can be a great enrichment as it is complex field with many layers.

My Mentoring Topics

• Regulatory Affairs of medical devices
• Quality Management System processes in the medical device industry
• Risk Management
• International regulatory strategy
• Compliance
• Project Management
• Intercultural communication