Shinji
I changed my job in January. I am an associate in charge of regulatory affairs at a medical device company. To be exact, I am not a regulatory affairs specialist. My office is in a factory and the specialists are in the headquarters. They register our products so that they can be sold in the market in each country. They need to communicate well with the staff at R&D department to get information for the registration, but RA specialists are not R&D experts and vice versa. My job is to be a bridge to assist their communication regarding product changes, submissions, international device registrations, and quality management systems. I have much things to learn because I have to understand both regulatory affairs and R&D. I will do my best.
Nov 1, 2021 1:54 PM
Shinji
Language Skills
English, Italian, Japanese
Learning Language
English, Italian