Di Lu
Associate Director Regulatory Affairs @ MCRA, an IQVIA business
United States
Washington DC-Baltimore Area
Medical Device
Failure Mode and Effects Analysis (FMEA), Usability Engineering, Patent Prosecution, Strategy, Research, Project Management, Communication, Problem Solving, Python (Programming Language), SOLIDWORKS, Medical Devices, Patent Law, Patent Analysis, Business Analysis, Regulatory Affairs, Research and Development (R&D), Prototyping
Experience
Associate Director Regulatory Affairs
MCRA, an IQVIA business
Lead and manage human factors service, SME for human factors and usability engineering, manage regulatory submissions
Manager, Regulatory Affairs
MCRA, an IQVIA business
Washington, District of Columbia, United States
Lead human factors service line, SME for human factors and usability engineering; Executive MedTech Advisory Council member 2025-2026
Regulatory Affairs Associate
MCRA, an IQVIA business
Washington, District of Columbia, United States
Specialize in human factors and usability engineering across all therapeutic areas including combination devices; developed usability engineering files and study protocols to support US and EU pre market submission; specialize in FDA pre market submission for SaMD, SiMD, and other digital health devices
Lecturer
Johns Hopkins Center for Bioengineering Innovation & Design
Teach students workshops on usability engineering, regulatory affairs, medical device patent strategy and prosecution.
Surgical Implant Innovation for Proximal Junctional Kyphosis (PJK) Prevention
Johns Hopkins Center for Bioengineering Innovation & Design
Baltimore, Maryland, United States
- Determined unmet clinical needs within the field of Orthopedics and Neurosurgery through 300+ hours of clinical/surgical shadowing, 50+ physician interviews, and paper research - Designed a surgical implant that helps prevent proximal junctional kyphosis for long spinal fusion patients
Preoperational Patient Monitoring and Assessment Device for Spine Surgeons
Johns Hopkins Center for Bioengineering Innovation & Design
Baltimore, Maryland, United States
- Designing a wearable patient monitoring device to provide information for neurological surgeons and orthopedic spine surgeons to better assess patients' posture and spinal curvature - Designing user interface, implementing machine learning algorithm for recognizing abnormality in patient's dynamic posture data in Python
Endoscopic Spine Surgical Tool Kit Development
Johns Hopkins Center for Bioengineering Innovation & Design
Baltimore, Maryland, United States
- Designing an endoscopic spine surgical tool kit - Working in a team of 4, in collaboration with Atlantic Spine Center in New Jersey and Asian Spine Center in Hyderabad, India - Sending out two surveys to more than 300 endoscopic spine surgeons worldwide, conducted more than 20 physician interviews to identify and validify tooling needs for both developed and developing world
CEO & Co-founder
Shanghai Zhichanli Innovation Management Co. Ltd
Shanghai, China
- Participated in R&D projects, strategically planned R&D directions, and constructed IP portfolios for client companies - Established patent pools for client companies; provided patent analysis, patent opinions, product evaluations
Education
The Johns Hopkins University
Bioengineering Innovation and Design
Northwestern University Pritzker School of Law
In progress
University of Virginia
Double major in Mechanical Engineering and Philosophy, minor in Material Science
Di Lu's Contact Information
Phone
Find the Right Leads
Find Verified Contact Data
What LeadContact does well
Find verified emails, phone numbers, and decision-makers with 98% accuracy.
Find Leads
Find the right people by company, role, industry, location, and more.
925M+ professional profiles
Find Emails
Access verified email addresses for your target contacts.
657M+ emails
Find Phone Numbers
Get cross-validated phone data from multiple top sources.
239M+ phone numbers
More Accurate. Lower Cost.
Find contact data in 1 tool with 98% accuracy
LeadContact integrates leading enrichment tools to deliver more accurate contact data—without paying for each one.
Great conversations start with the right contact.
It’s time to find yours.