Associate Regulatory Affairs Manager (San Diego) - Bilingual (Mandarin Speaking)
CorDx
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.
Job description
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
Requirements
- Master's degree in Regulatory Affairs, Life Sciences, Engineering, or a related field
- 4-6 years supporting or managing 510(k) submissions and regulatory filings
- Experience participating in regulatory audits and inspections preferred
- Strong organizational, document management, and project coordination skills
- Excellent communication, problem-solving, and cross-functional collaboration abilities
- Detail-oriented with the ability to manage multiple regulatory projects and priorities
- Proficient in Microsoft Office and regulatory document management systems
- Ability to work independently and proactively while seeking guidance for complex issues
Benefits
- Medical, Dental & Vision
- 401(k) Matching
- Flexible PTO
- Competitive Compensation
Company overview
CorDx is a biotechnology company specializing in the development and manufacturing of rapid diagnostic solutions. The company focuses on creating innovative point-of-care testing technologies that provide accurate and timely results for various medical conditions. With expertise in lateral flow assay development and molecular diagnostics, CorDx aims to make healthcare more accessible through portable, easy-to-use testing platforms. The company's research efforts are directed toward infectious disease detection, chronic condition monitoring, and preventive healthcare screening. CorDx operates at the intersection of biotechnology and medical diagnostics, leveraging advanced materials science and bioengineering to create reliable testing solutions that can be deployed in diverse healthcare settings, from clinical laboratories to remote field locations. Their commitment to improving diagnostic accessibility aligns with global healthcare needs for rapid, affordable, and accurate testing methodologies.