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 a Regulatory Affairs Manager to support the preparation and submission of regulatory documentation for medical device products in San Diego, California. This role involves collaboration with cross-functional teams, ensuring compliance with FDA, ISO 13485, and other standards. The position provides regulatory input during product development and throughout the product lifecycle.
Requirements
- Prepare, review, and coordinate the submission of regulatory documents.
- Ensure product compliance with FDA regulations and ISO 13485.
- Stay current on regulatory requirements and assess their impact on processes.
- Perform regulatory assessments and propose regulatory pathways.
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
