Rebecca Blank Reiter
Regulatory Affairs Project Leader @Johnson & Johnson MedTech
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WORK HISTORY
Regulatory Affairs Project Leader @Johnson & Johnson MedTech
West Chester, PA, US
EDUCATION
Rensselaer Polytechnic Institute
Bachelor of Science (BS), Biomedical Engineering, Psychology Minor
ABOUT REBECCA BLANK REITER
Experienced Regulatory Affairs Leader in registrations, audits, inspections and medical device industry-related regulatory proceedings. Analytical, detail-oriented professional focused on ensuring products meet all relevant domestic and international regulatory requirements. Sound judgement, critical thinking and problem solving skills with a high focus on patient care. Specific focus includes 510(k) FDA Premarket Notifications for the United States and CE Marking for EU markets. Specific clearances and conformity assessments include medical device types; plates, screws, nails, and external fixation devices. Highlighted skills set includes Medical Devices, ISO Standards, 21 CFR, Design Control, people leadership, problem solving, regulatory strategy, team player.
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