Regulatory Manager- IVD and 510(k)
CorDxSan Diego, California, United States
Posted June 3, 2025
90000 - 150000 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 is a multi-national biotech organization seeking a highly motivated and experienced Regulatory Specialist to join their Regulatory Affairs team.
Requirements
- Bachelor’s degree in Life Sciences, Biotechnology, Regulatory Affairs, or a related field.
- Minimum of 5 years of experience in relevant industry with min or 3 year hands on experience in 510(k) preparations and submissions.
- Strong understanding of FDA regulations, guidance documents, and processes related to IVD products.
- Experience in interacting with regulatory agencies, particularly the FDA.
- Excellent analytical, organizational, and communication skills.
- Detail-oriented with the ability to manage multiple projects simultaneously.
- RAC certification or similar.
Benefits
- Health Care Plan (Medical)
- 401K
- Paid Time Off and Paid Sick Leave
- Training & Development