Regulatory Affairs Specialist
About the job
- A bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, or a related field is required.
- Two to three years of regulatory affairs experience within the medical device or in vitro diagnostic industry.
- Working knowledge of 510(k) submissions and regulatory documentation processes.
- A solid understanding of Food and Drug Administration regulations and guidance, including 510(k), premarket approval, and De Novo pathways.
- Strong organizational and project management skills, including the ability to manage multiple projects and priorities.
- Ability to manage document workflows.
- Prepare, review, and coordinate submissions of regulatory documents, including 510(k) submissions, technical files, and other filings to regulatory agencies.
- Ensure product compliance with Food and Drug Administration regulations, ISO 13485, and applicable international standards.
- Work with product development teams on analytical performance tests and draft documentation.
- Perform regulatory assessments for product changes and propose appropriate regulatory pathways.
- Maintain documentation and records of regulatory submissions and correspondence.
- Support preparation for regulatory agency meetings, audits, and inspections.
- Experience interacting with the Food and Drug Administration and other regulatory agencies.
- Mandarin language proficiency.
About the company
CorDx is a multinational biotech organization that provides rapid testing and point-of-care diagnostic devices. Its products are designed to quickly detect infectious diseases (like COVID-19), pregnancy, drugs of abuse, biomarkers, and other health indicators directly at the patient’s side. The devices work by offering fast diagnostic tests and wearable or handheld systems that deliver results on-site, often supported by data science and artificial intelligence to improve accuracy and capture health data. CorDx differentiates itself from competitors through its global reach (2,100+ employees in over 100 countries), scale, and its emphasis on integrating AI and data-driven insights to enhance diagnostic solutions. The company aims to help answer critical health questions by delivering practical, accessible diagnostics and moving toward personalized healthcare.
Company Size
51-200
Company Stage
N/A
Total Funding
N/A
Headquarters
Atlanta, Georgia
Founded
2006
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Simplify's Take
What believers are saying
- CorDx secured an FDA EUA for Tyfast Flu A/B and COVID-19 in 2024.
- The 2025 Singapore POCT Centre broadens access to infectious, fertility, and chronic-disease programs.
- CorDx opened a new Singapore facility in 2026, strengthening global manufacturing reach.
What critics are saying
- FDA authorization still governs key products like Tyfast and COVID-19 Ag under emergency use.
- Singapore expansion raises fixed costs while diagnostics demand remains volatile after pandemic-era normalization.
- Any U.S. FDA or EU IVDR setback would strand CorDx's multiplex-test commercialization roadmap.
What makes CorDx unique
- CorDx spans R&D, manufacturing, and supply chain across the U.S., China, and Singapore.
- The 2025 DxD Hub POCT Centre deepens CorDx's Singapore diagnostics collaboration.
- MasterControl adoption signals a compliance-first operating model across global quality and manufacturing systems.
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Benefits
- Health Insurance
- Dental Insurance
- Vision Insurance
- Training Programs
- Paid Vacation
- 401(k) Retirement Plan
- Meal Benefits