Regulatory Affairs Specialist
cordxAlpharetta (GA)
About the role
Regulatory Affairs Specialist 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. 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
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