Regulatory Affairs Manager (Atlanta)

Regulatory Affairs Manager

CorDx, a multi-national biotech organization focused on pushing the limits of innovation and supply in global health, 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

Location : Onsite - Atlanta, or San Diego

Position Summary :

The Regulatory Affairs Manager will support the preparation, review, and submission of regulatory documentation for medical device products, ensuring compliance with applicable regulatory requirements including FDA, ISO 13485, and other global standards. This position collaborates with cross-functional teams to provide regulatory input during product development and throughout the product lifecycle, 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.
• Provide regulatory support to product development teams by offering guidance on applicable regulations and documentation requirements.
• Stay current on changes in regulatory requirements and assist in assessing the impact on company processes and products.
• 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.
• Collaborate with internal departments such as R&D, Quality, and Operations to ensure regulatory deliverables are met in a timely manner.