Principal Regulatory Affairs Specialist

Mondo

Norcross, GA

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

Posted 2025-08-07

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