Iris Kim Marklein

Iris Kim Marklein: Email & Phone Number

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Senior Director, Regulatory Affairs at MCRA, an IQVIA business|Washington, District of Columbia, United States

Position:

Senior Director, Regulatory Affairs at MCRA, an IQVIA business

Location:

Washington, District of Columbia, United States

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Last updated: 2024-08-28
Updated: 2024-08-28

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Work Experience 19 years

Senior Director, Regulatory Affairs at MCRA, an IQVIA business

Oct 2023 - Current

Associate Director for Policy at FDA

Feb 2020 - Oct 2023

Cell Therapy CMC & Device Reviewer at FDA

Jun 2019 - Feb 2020

Regulatory Affairs Advisor, Assistant Professor of Practice at University of Georgia College of Engineering

Oct 2018 - May 2019

Device and Combination Products Team Lead at FDA

Jan 2017 - Sep 2018

Cell Therapy CMC & Device Reviewer at FDA

May 2016 - Jan 2017

Lead Reviewer | Orthopedic Devices, Center for Devices and Radiological Health at FDA

Sep 2014 - May 2016

Ph.D. Candidate at University of Pennsylvania

Aug 2009 - Aug 2014

Research Assistant at The University of Texas at Austin

Aug 2007 - Jun 2008

REU Summer Intern at Rice University

May 2007 - Aug 2007

Iris Kim Marklein started working in 2007, then the employee has changed 5 companies and 8 jobs. On average, Iris Kim Marklein works for one company for 1 year 9 months.

Their professional focus is Atomic Force Microscopy, CellProfiler, and Cell Viability Assays across 3 core areas.

Education

Doctor of Philosophy (Ph.D.) at University of Pennsylvania

Bachelor of Science (B.S.) at The University of Texas at Austin

Skills

ELISA, Scanning Electron Microscopy, Electrospinning, Confocal Microscopy, Traction Force Microscopy, Atomic Force Microscopy, ImageJ, CellProfiler, Cell Viability Assays, Ex vivo Tissue Analysis, Chemotaxis, real-time PCR, Mechanical Testing, Histology, Stem Cell Research, Mammalian Cell Culture, Immunohistochemistry

Iris Kim Marklein Namesakes

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Iris Kim Marklein
Senior Director, Regulatory Affairs
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Iris Kim Marklein
Johnson & Johnson Innovative Medicine
Director, Global Regulatory Lead
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