Regulatory Coordinator in Georgia

CorDx, a thriving biotechnology company, is seeking a Regulatory Coordinator to join our team. In this role, you will assist in the planning and execution of regulatory compliance activities. You will analyze and interpret regulations and guidelines to ensure company compliance and organize necessary documentation. The ideal candidate will be detail-oriented and possess excellent organizational and communication skills.

Responsibilities

• Assist in the preparation, submission, and maintenance of regulatory filings and registrations, including 510(k) and PMA submissions.
• Interpret and communicate industry and regulatory guidance to internal teams.
• Coordinate with cross-functional teams to ensure compliance with regulatory requirements.
• Manage documentation related to regulatory submissions and approvals.
• Prepare post-market surveillance reports, adverse event reports, and other regulatory reports.
• Track and maintain...