Principal Regulatory Affairs Specialist
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:
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Develop regulatory plans for new and modified products
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Author FDA 510(k)
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Serve as regulatory representative on cross-functional design teams
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Review technical documentation, product labeling, and commercial materials for compliance
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Coordinate with internal teams and the FDA to ensure timely approvals
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Prepare and review summary analytical and clinical reports
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Support change management and documentation control processes
Requirements:
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Must-Haves:
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5 years' experience in regulatory affairs, ideally with IVD or medical devices
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Minimum of 3 years regulatory experience; quality systems background acceptable
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Strong FDA 510(k) experience (5–10 submissions preferred)
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Understanding of QMS (including postmarket surveillance, documentation)
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Strong English communication and technical writing skills
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Bachelor's degree in Human or Physical Sciences (Master's preferred)
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Self-starter with cross-functional collaboration skills
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Nice-to-Haves:
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Experience with labeling and regulatory compliance reviews
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Blood banking or biologics knowledge
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Small team project management experience
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