Principal Regulatory Affairs Specialist

Job Description

Job Description

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