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

CorDx; San Diego (CA); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Highly competitive compensation

Medical, dental, vision insurance

401(k) plan with company contributions

Flexible PTO

Additional substantial benefits

Job summary

CorDx is seeking an Associate Regulatory Affairs Manager to support development, review, and submission of regulatory documents for medical devices and IVD products. You will ensure FDA and ISO 13485 compliance, coordinate with internal teams and external partners, and drive timely approvals across a global lifecycle.

The role requires a Master’s degree and 4–6 years’ experience with 510(k) submissions, audits, and strong project coordination.

Qualifications

• Master's level degree required or equivalent.
• Experience with 510(k) submissions and regulatory filings.
• Strong organizational and project coordination skills.
• Excellent communication and cross‑functional collaboration abilities.
• Detail‑oriented with ability to manage multiple projects.

Responsibilities

• Assist in preparing, reviewing, and submitting regulatory documentation for new products and changes.
• Support 510(k) submissions, Technical Files, and other filings.
• Provide regulatory guidance to cross‑functional teams during development and post‑market activities.
• Track submission timelines and regulatory project plans.

Skills

Regulatory submissions

FDA regulatory

Cross-functional collaboration

Regulatory audits

Documentation management

Education

Master's degree in Regulatory Affairs/Life Sciences/Engineering

Job description

Who Is CorDx？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.

Who Is CorDx？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 Job Title: Associate Regulatory Affairs Manager 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

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

• 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

Equal Opportunity Statement: We are an equal opportunity employer committed to inclusion and diversity. We do not discriminate based on race, gender, religion, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any other protected characteristic.