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PATRICK LEE, M.B.A., M.S., PE, RAC, director of regulatory affairs at BioCardia, Inc., is a regulatory affairs / QA professional with over 25 years of experience in FDA–regulated industries including health-care, medical device, and nutritional products. He formerly served as the senior director of regulatory affairs and quality assurance at Vascular Dynamics, Inc. (VDI). Neuro-implants, cardiovascular devices, laser devices, cell therapy biologics, blood processing and stem cell harvesting devices are a few product categories he has worked in.

Patrick Lee's courses currently open for enrollment

Global Medical Device Submissions and Strategy

REGL.X401
$750
  • Live-Online Attend via Zoom at scheduled times.
Schedule
Date
Start Time
End Time
Meeting Type
Location
Sat, 11-22-2025
8:30am
1:30pm
Live-Online
REMOTE
Sat, 11-22-2025
8:30am
1:30pm
Live-Online
REMOTE
Sat, 12-06-2025
8:30am
1:30pm
Live-Online
REMOTE
Sat, 12-06-2025
8:30am
1:30pm
Live-Online
REMOTE
Sat, 12-13-2025
8:30am
1:30pm
Live-Online
REMOTE
Sat, 12-13-2025
8:30am
1:30pm
Live-Online
REMOTE
 

This class is offered in an online synchronous format. Students are expected to log into this course via Canvas at the start time of scheduled meetings and participate via Zoom, for the duration of each scheduled class meeting.

To see all meeting dates, click “Full Schedule” below.

Electronic Course Materials: You will be granted access in Canvas to your course site and course materials approximately 24 hours prior to the published start date of the course.

Recommended Tools and Materials:
Microsoft Office suite of applications (Word, Excel, PowerPoint)

Associated Program(s)