Associate Regulatory Affairs Manager (San Diego) - Bilingual (Mandarin Speaking)

Associate Regulatory Affairs Manager

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 Type: Full time Location: Onsite - San Diego, CA

Position Summary:

The Associate Regulatory Affairs Manager will support the development, review, and submission of regulatory documents for medical device and IVD products. This role will assist in managing regulatory projects, ensuring compliance with FDA, ISO 13485, and other global regulatory requirements. The Associate Manager will work cross-functionally with internal teams and external partners to support product approvals and maintain regulatory compliance throughout the product lifecycle.

Key Responsibilities:

• Assist in the preparation, review, and submission of regulatory documentation for new products, product changes, and ongoing compliance.
• Support the regulatory submission process for 510(k), Technical Files, and other regulatory filings.
• Provide regulatory guidance to cross-functional teams during product development and post-market activities under the direction of senior management.
• Help track and manage submission timelines, regulatory project plans, and documentation.
• Stay informed on changes in FDA, ISO 13485, IVDR, and other global regulations, communicating relevant updates to the team.
• Conduct regulatory assessments for product modifications and assist in defining appropriate submission strategies.
• Participate in internal and external audits, inspections, and regulatory agency communications as assigned.
• Contribute to the maintenance of regulatory files and submission records in accordance with internal procedures and regulations.
• May provide oversight and mentorship to junior staff or specialists on assigned projects.