Regulatory Affairs Manager (Atlanta)
CorDxAtlanta, Georgia, United States
Posted May 12, 2025
Full Time
About the Company
CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 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 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. #Biotechnology #Pharmaceuticals #Diagnostics #Healthcare #PersonalisedHealthcare #GreatPlaceToWork #Innovation
Job Description
CorDx is seeking a Regulatory Affairs Manager to support the preparation, review, and submission of regulatory documentation for medical device products. The role involves ensuring compliance with FDA regulations, ISO 13485, and other global standards, collaborating with cross-functional teams, and providing regulatory input throughout the product lifecycle. The company delivers rapid testing and point-of-care medical device solutions in infectious disease detection.
Requirements
- Prepare, review, and coordinate submissions to regulatory agencies.
- Ensure product compliance with FDA regulations, ISO 13485, and applicable international standards.
- Provide regulatory support to product development teams.
- Stay current on regulatory requirements and assess their impact.
- Perform regulatory assessments and propose regulatory pathways.
- Maintain documentation and records of submissions and correspondence.
- Support regulatory agency meetings and audits.
- Collaborate with internal departments.
Benefits
- Highly competitive compensation package.
- Comprehensive medical, dental, and vision insurance.
- 401(k) plan with generous company contributions.
- Flexible paid time off (PTO) policy.