QA/RA Specialist

CAIRE • Ball Ground, GA

9h • Onsite

About The Position

As a Quality Assurance & Regulatory Affairs Specialist, you will work with the FDA and international regulatory bodies on product submissions, audits, and event reporting. You will participate in cross-functional teams for new product development and changes to existing products to ensure regulatory compliance. You will also be part of the team that maintains the quality management system.

Requirements

• Bachelor’s degree from a four-year college or university, preferably an engineering or technical degree or equivalent work experience
• Good communication skills at all levels (written and verbal)
• Ability to plan and manage multiple tasks/projects

Nice To Haves

• Master’s degree a plus
• Co-op or internship preferred

Responsibilities

• Ensure product/process compliance with the US and international requirements
• Work with Engineering on new product releases and changes to develop Regulatory Plans
• Work with Design and Development Project teams to ensure compliance with Design Control Requirements
• Work with the FDA on product submissions
• Initiate US and International product submissions and registrations
• Participate in internal and external audits
• Reporting of adverse events to FDA
• Other duties as assigned

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level