Andrea Armando

How did you get into a regulatory career? What do you like about regulatory affairs?

Like many others, I got into a regulatory career by chance. The company I worked for decided to start designing medical devices and offered me a regulatory position. I accepted and immediately realized I made the right choice. I love working in regulatory as no two days are the same—it is a wide, “horizontal” career that allows me to know and work on multiple aspects of medical technologies.
 

What was an especially memorable moment for you on the job?

In 2020, the company I work for developed and placed on the market several in vitro diagnostic (IVD) assays for the detection of the SARS-CoV-2 virus. Everybody, from R&D to manufacturing, spared no effort to make these assays available as soon as possible. I was proud to play my part in this endeavor, and when the first kit left the factory—that was indeed a memorable moment.
 

How were you introduced to RAPS?

One of my former bosses introduced me to RAPS, asking me if I would be interested in participating in a Convergence event. This was such an interesting and stimulating experience that I decided to join RAPS and become more involved in the regulatory community.
 

What motivated you to pursue the RAC certification?

I got my RAC Devices certification in Spring 2019. To prepare for the exam, I had to review and learn several topics which I was not very familiar with, allowing me to deepen my regulatory knowledge. Until I started to study for the RAC exam, I only had regulatory experience on medical devices. Getting the RAC certification forced me to expand my knowledge to IVDs, which proved very useful since soon thereafter I joined an IVD company and was able to hit the ground running.
 

What steps would you recommend to someone thinking about achieving certification?

Join a regulatory community, and don't be afraid to ask for help and advice!