Principal Regulatory Affairs Specialist

2 weeks ago

Norcross, GA, United States Mondo Full time
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

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