Regulatory Manager- IVD and 510(k)
CorDx
About this role
CorDx is a multinational biotechnology company developing point-of-care diagnostic and IVD solutions for global health. The Regulatory Manager - IVD and 510(k) will be part of the Regulatory Affairs team in San Diego, focusing on regulatory strategy and submissions to ensure products meet FDA and other regulatory requirements. This is a full-time, onsite role supporting the company’s commercialization efforts.
Skills
Qualifications
About CorDx
cordx.comCorDx is a global diagnostics organization dedicated to delivering essential health insights. The company partners with various organizations worldwide to develop, manufacture, and supply diagnostic tools that empower users to monitor and enhance their health. CorDx's innovative solutions help individuals make informed health decisions, ensuring timely access to critical information.
Recent company news
Business WireUC San Diego Celebrates the Naming of the Aiiso Yufeng Li Family Department of Chemical and Nano Engineering
Apr 8, 2025
UC San Diego Today$3 Million Gift from CorDx to Boost Sustainable Energy Innovation at UC San Diego
Feb 8, 2024
www.a-star.edu.sgCorDx and DxD Hub Establish POCT Centre to Drive Global Health Innovation in Infectious Diseases, Fertility Health and Chronic Diseases Diagnostics
Oct 23, 2025
freebeacon.comBiden Admin Gave $86 Million to Company Accused of Peddling Fake COVID Test Kits
Dec 5, 2023
Drug Store NewsBDSC Company to distribute CorDx Flu A/B & COVID-19 At-Home Rapid Test
May 28, 2024
About CorDx
Headquarters
San Francisco, CA
Company Size
201-500 employees
Founded
2018
Industry
Technology
Glassdoor Rating
4.2 / 5
Leadership Team
Sarah Johnson
Chief Executive Officer
Michael Chen
Chief Technology Officer
Emily Williams
VP of Engineering
David Rodriguez
VP of Product
Jessica Thompson
Chief Financial Officer
Andrew Park
VP of Sales
Unlock Company Insights
View leadership team, funding history,
and employee contacts for CorDx.
Salary
$90k – $150k
per year
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