Associate Regulatory Affairs Manager (San Diego) - Bilingual (Mandarin Speaking)
CorDxSan Diego, California, United States
Posted July 20, 2025
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 seeking an Associate Regulatory Affairs Manager to support the development, review, and submission of regulatory documents for medical device and IVD products. This role involves assisting with regulatory submissions, maintaining compliance, and staying informed about global regulations. The role supports product approval and ensures adherence throughout the product lifecycle.
Requirements
- Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related field
- 4–6 years of regulatory affairs experience in the medical device or IVD industry
- Experience supporting or managing 510(k) submissions and regulatory filings
- Familiarity with FDA regulations (21 CFR Part 820), ISO 13485, and international medical device regulations
- Experience participating in regulatory audits and inspections
Benefits
- Highly competitive compensation package
- Comprehensive medical, dental, and vision insurance
- 401(k) plan with generous company contributions
- Flexible paid time off (PTO) policy
- Additional substantial benefits