Interview with Qserve's Consultant Regulatory Affairs, Mari Leong
1. Tell us a bit about yourself.
I am originally from Japan and have been living in the U.S. since my undergraduate career. I have a Bachelor’s degree in Political Science from the University of California, San Diego, and am currently pursuing a Master’s degree in Regulatory Science at the University of Southern California.
2. What does a typical Qserve working week look like?
I mostly work from home unless I am meeting with a client. Qserve has been receiving numerous MDR compliance projects, so a lot of my time is spent conducting gap analyses for Technical Files/Design Dossiers/Clinical Evaluation Reports. Every week, I manage projects for 2-3 clients, and it is a never-ending learning process researching regulations and guidance documents, as well as different types of products!
3. How would you describe your work experience as a Regulatory Affairs Consultant with Qserve?
What I love about Qserve is being able to share knowledge and experience with my brilliant colleagues who are true industry experts. The work is challenging and the learning curve is steep, but I always feel supported because the company really cares about professional development. It is also a huge bonus that our team is incredibly diverse, we all respect each other, and our team meetings are always fun!
4. What is your specialization?
I have extensive experience in global regulatory strategy development/ implementation for non-active medical devices. Prior to joining Qserve, I specialized in neurovascular guidewires, catheters, and stents.
5. What do you hope your position contributes to the team?
Every experience with each client is unique and provides great learning opportunities. I hope to share my knowledge and experience with my colleagues as much as I can to make it a learning experience for the company, as a whole. Also, with my language background, I hope to help attract more business with clients in Japan.
Do you wish to know more about our work and how we can assist you? Then feel free to contact Qserve, we are always happy to discuss some details.
Meet our Qserve team at the RAPS Regulatory Convergence 2018!