Regulatory Director- IVD and 510(k)
CorDxSan Diego, California, United States
Posted March 4, 2025
100000 - 200000 USD year
Full Time
About the Company
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. #Biotechnology #Pharmaceuticals #Diagnostics #Healthcare #PersonalisedHealthcare #GreatPlaceToWork #Innovation
Job Description
CorDx Inc. is seeking a highly skilled Director of Regulatory Affairs to lead 510(k) submissions for their IVD products. This role involves overseeing regulatory strategies, FDA interactions, and compliance efforts to ensure successful market clearance. The ideal candidate will have in-depth knowledge of the 510(k process and experience in cross-functional collaboration.
Requirements
- Bachelor’s or Master’s degree in Regulatory Affairs, Life Sciences, Biomedical Engineering, or a related field.
- Minimum of 8-10 years of experience in IVD or medical device regulatory affairs, with a focus on 510(k) submissions.
- Extensive knowledge of FDA 510(k) submission requirements, Q-Sub, and post-market requirements.
- Proven experience in preparing and submitting successful 510(k) applications and responding to FDA inquiries.
- Strong understanding of regulatory frameworks (21 CFR Part 807, ISO 13485, IVDR, CLIA).
Benefits
- Health Care Plan
- 401K
- Paid Time Off
- Paid Sick Leave
- Training & Development