Job Title: Principal Regulatory Affairs Specialist
Location-Type: Hybrid Preferred (Norcross, GA) – Open to remote or relocation for highly qualified candidates
Start Date: ASAP
Job Type: Direct Hire
Compensation Range: $100,000 – $130,000 annually bonus
Job Description:
Lead U.S. regulatory activities for pre-market submissions, ensuring full compliance with FDA requirements for IVD and medical device products.
Day-to-Day Responsibilities:
Develop regulatory plans for new and modified products
Author FDA 510(k)
Serve as regulatory representative on cross-functional design teams
Review technical documentation, product labeling, and commercial materials for compliance
Coordinate with internal teams and the FDA to ensure timely approvals
Prepare and review summary analytical and clinical reports
Support change management and documentation control processes
Requirements:
Must-Haves:
5 years' experience in regulatory affairs, ideally with IVD or medical devices
Minimum of 3 years regulatory experience; quality systems background acceptable
Strong FDA 510(k) experience (5–10 submissions preferred)
Understanding of QMS (including postmarket surveillance, documentation)
Strong English communication and technical writing skills
Bachelor's degree in Human or Physical Sciences (Master's preferred)
Self-starter with cross-functional collaboration skills
Nice-to-Haves:
Experience with labeling and regulatory compliance reviews
Blood banking or biologics knowledge
Small team project management experience