Regulatory Affairs Manager (Atlanta)

CorDx(8 months ago)

Atlanta, USOnsiteFull TimeManager$0 - $0Regulatory Affairs

About this role

The Regulatory Affairs Manager at CorDx leads regulatory documentation and submission efforts for medical device and IVD products, ensuring compliance with FDA, ISO 13485, and international standards. The role supports product development and lifecycle activities to secure timely regulatory approvals and clearances. This is a full-time, onsite position based in Atlanta, GA at a multinational biotech company focused on diagnostic and point-of-care devices.

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Required Skills

Regulatory Submissions
510(k) Submissions
FDA Regulations
ISO 13485
Regulatory Assessments
Project Management
Document Workflows
Cross-Functional Collaboration
Communication
Problem Solving

Qualifications

Bachelor’s Degree (Regulatory Affairs/Life Sciences/Engineering)
Master’s Degree (Preferred)

About CorDx

cordx.com

CorDx is a global diagnostics organization dedicated to delivering essential health insights. The company partners with various organizations worldwide to develop, manufacture, and supply diagnostic tools that empower users to monitor and enhance their health. CorDx's innovative solutions help individuals make informed health decisions, ensuring timely access to critical information.