AMA for the Regulatory Affairs and Quality Systems applications in medical device companies.
Hi everyone! I am a Regulatory Affairs and Quality Systems Document Specialist at a medical device company. I’ve been in the position for over 5 years and graduated with my B.S. in Biological Engineering with a concentration in Biomedical and a M.S. in Biomedical Sciences. I made a comment on a post here recently with people asking more about the field, so I thought I make this AMA to give anyone the opportunity to ask questions. I’ll do my best to answer them. When I was in school, I did not know this field was even existed in the medical device world, so I want to give it some light and share what I can. If you are also in the field, please feel free to answer as well!