Interview with Qserve's Principal Consultant Regulatory Affairs, Lorry Weaver Huffman
1. Tell us a bit about yourself.
Growing up, my father was in the US Air Force, so I lived in several places that probably created my love of travel and
learning about people all over the world. My family finally settled in Arizona, and after college, I moved to California and have lived there ever since. I have 3 grown children and live with my dog, Jack, and rabbit, Pepper.
2. What does a typical Qserve working week look like?
I am typically working by 7:00 am, and after catching up on emails, I plan my activities for the day, dividing my time between client work. Each week, I work from home 4 days and spend one day at a client location. Daily work includes activities such as editing and advisory write-ups for clients, drafting procedures, peer reviews, preparing materials for training workshops, and speaking with prospective clients and preparing consulting proposals.
3. How would you describe your work experience as a regulatory consultant with Qserve?
I joined Qserve in June, 2017. It has been interesting adjusting to the work culture, which differs from my previous positions in medical device and in vitro diagnostics manufacturing businesses. My regulatory application has always been from the business viewpoint. I’ve been fortunate to assist clients as their regulatory expert, and work with them in many capacities to move projects in the right compliance direction, while meeting business goals. To coin Qserve’s familiar phrase “A practical approach”, my style has always been to ask, “what do you want to do?” and then figuring out how to achieve it within the regulations. t is not uncommon to have a conversation with colleagues in Europe in the morning, U.S. colleagues during the day and then colleagues in China as my day comes to a close. Very enriching and satisfying professionally.
4. What is your specialization?
My specialty is Regulatory Affairs, specifically in new product development and design changes of
existing products. I have worked extensively with US regulations in both medical devices and in vitro diagnostics, as well as the European regulations. Over the course of several years, I learned the Japanese regulations when I organized a Regulatory and Quality system at a former employer’s office in Tokyo.
5. What do you hope your position contributes to the team?
I feel I bring the ‘voice’ of regulation in business to my colleagues, who view things from a regulator’s perspective. There has to be a balance, where goals, activities and
timelines are achieved,
while meeting regulations. It’s essential to understand the reasons behind specific regulatory points and concerns of the regulators, then create ways to address those issues. Things are not always black and white, and one size does not fit all.