Regulatory Manager- IVD and 510(k)

Who is CorDx？  
 

CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.  

Job Description

We are seeking a highly motivated and experienced Regulatory Specialist to join our Regulatory Affairs team. The ideal candidate will have a strong background in IVD (In Vitro Diagnostics) and experience with 510(k) preparation and submissions to ensure compliance with FDA and other regulatory body requirements.

Job Type: Full time 
Job Title: Regulatory Manager - IVD and 510(K)
Location: Onsite - San Diego

Salary Range: $90000-$150000/Yearly

Responsibilities

· Prepare and submit 510(k) applications for IVD products to ensure timely market entry.

· Manage all aspects of regulatory submission processes, including do