Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, or related field
2-3 years of regulatory affairs experience in medical device or IVD industry
Working knowledge of 510(k) submissions and regulatory processes
Experience with FDA interaction preferred
Fluency in English; Mandarin preferred
Responsibilities
Prepare and coordinate regulatory document submissions including 510(k) and technical files
Ensure compliance with FDA regulations and ISO 13485
Collaborate with product development on analytical performance test documentation
Conduct regulatory assessments for product changes and propose regulatory pathways
Maintain records of all regulatory submissions and communications
Support preparation for regulatory meetings, audits, and inspections
Benefits
Comprehensive medical insurance
401(k) plan with company contributions
Flexible paid time off (PTO) policy
Full Job Description
About Us
CorDx, a multi-national biotech organization, focused on pushing the limits of innovation and supply in global health. With over 2000 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 diseases such as COVID-19, pregnancy, drug 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.
Position Summary
The Regulatory Affairs Specialist will support the preparation, review, and submission of regulatory documentation for medical device/IVDs products, ensuring compliance with applicable regulatory requirements including FDA, ISO 13485, and other global standards. This position focus on submitted documents preparing, helping to secure timely product approvals and regulatory clearances.
Key Responsibilities
Prepare, review, and coordinate the submission of regulatory documents including 510(k), technical files, and other filings to regulatory agencies
Ensure product compliance with FDA regulations, ISO 13485, and applicable international standards
Working on analytical performance test with product development teams to draft documentation.
Perform regulatory assessments for product changes and propose appropriate regulatory pathways
Maintain documentation and records of all regulatory submissions and correspondence
Support the preparation for regulatory agency meetings, audits, and inspections
Requirements
Education:
Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, or a related field required
Language:
English
Mandarin Preferred
Professional Experience:
2-3 years of regulatory affairs experience within the medical device or IVD industry
Working knowledge of 510(k) submissions and regulatory documentation processes
Experience interacting with FDA and other regulatory agencies preferred
Skills & Competencies:
Solid understanding of FDA regulations and Guidance. (510k, PMA, De novo)
Strong organizational and project management skills with the ability to manage multiple projects and priorities
Excellent communication, problem-solving, and attention to detail
Ability to work collaboratively in cross-functional teams and manage document workflows
