US Regulatory Affairs Expert
US Principal Consultant Regulatory Affairs
MT (ASCP), CLS (NCA)
Lorry is part of the US Regulatory Affairs team, her area of expertise is 510(k) submission and European Medical Device legislation. Her main activities are supporting manufacturers with getting FDA clearance and CE marking for all kind of devices.
Lorry has been in the medical industry for over 30 years working in large multi-national corporations, mid-sized companies, clinical laboratories, and the consulting business. In this time, Lorry has developed Regulatory and Quality expertise spanning a broad range of product types. Product areas include Class II cardiovascular and renal devices, Class III cardiovascular implants, in vitro diagnostics ranging from standard microbe identification and antimicrobial susceptibility panels to genetic sequencing of bacteria, viruses, and tumor tissue as companion diagnostic (CDx) assays using next-generation sequencing (NGS). Expertise includes developing US regulatory strategies, engaging with FDA through pre-submissions (Q-subs) to partner with FDA and the manufacturer in developing novel regulatory pathways, writing IDEs, 510(k)s, and PMAs.
Lorry has international expertise having had global responsibilities in her past, namely Europe, Canada, Japan, and China. She earned her BS in Microbiology with a minor in Chemistry from Northern Arizona University and an MBA with Marketing emphasis from CSU-Sacramento. In addition, she is a licensed Medical Technologist and Clinical Laboratory Scientist with ASCP, NCA, and the State of California.
Lorry about working at Qserve:
"It has been so refreshing to work with such expert, professional colleagues across the globe and have intellectual discussion and healthy debate on regulations; how to interpret; how to apply them; and best practices we have seen. Everyone respects each other and is truly interested in each other’s input and viewpoint. It 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. Together, we are creating valuable work product for our customers and being sought after as experts in global regulation. Inspiring company to work for."
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Learn more about our services within Regulatory Affairs.