Jayne Kim

Assistant Director, Regulatory Affairs

Role: Assistant Director, Regulatory Affairs at NYU Langone Health
Location: New York, NY, US
LinkedIn followers: 500 followers

About Jayne Kim

Regulatory Affairs professional with demonstrated experience working in biotechnology startup and clinical research spaces. Strong technical background with a PhD in Biomedical/Medical Engineering.

Experience

Assistant Director, Regulatory Affairs
NYU Langone Health
Jan 2022 — Present · New York, NY, US
Guide the development and coordination of FDA submissions, including Investigational New Drug (IND), Investigational Device Exemption (IDE), and premarket (e.g, 510(k)) applications.• Facilitate emergency use requests of investigational drugs and devices to FDA• Collaborate with IRB and investigators in making IND Exemption, IDE Exemption, and Study Risk Determinations • Oversee centralized ClinicalTrials.gov registration, reporting processes, and staff • Manage iConnect suite of clinical research utilities (Clinical Studies Registry, Referral Manager, Volunteer Registry, and Outreach Campaign Tracker)• Together with the Director, serve as the internal subject matter expert on regulatory affairs – maintain up-to-date knowledge on FDA/international regulatory requirements and current practice standards for clinical trials including regulatory submissions• Contribute significantly to the development, implementation, and ongoing evaluation of strategies and processes to ensure that FDA-regulated research at the institution is conducted in accordance with all required regulations• Supervise, train, and mentor regulatory staff members • Consult on the effort and budget required for regulatory activities in the submission of funding proposals• Serve as member of Compliance Oversight Committee• Support the implementation and maintenance of institutional IND/IDE Sponsor/Sponsor-Investigator standard operating procedures (SOPs)• Develop and execute the Regulatory Affairs educational program to facilitate compliance with regulatory requirements, federal regulations, and institutional policies/SOPs

Education

The Ohio State University
Doctor of Philosophy (Ph.D.), Biomedical/Medical Engineering
2010 — 2015
The Ohio State University
Master's Degree, Biomedical/Medical Engineering
2010 — 2013

Skills

Higher Education
Imagej
Research
Dynamic Mechanical Testing
Torsional Ballistometry
Biomedical Engineering
Microsoft Office
Hematoxylin and Eosin (H&E) Staining
Sigmaplot
Clinical Photography
Microsoft Word
Ln2 Tissue Pulverizer
Cutometry
Confocal Microscopy
Electrospinning
Public Speaking
Autocad
Btc2000
Laboratory
Matlab
Clinical Research
Dermalab Combo
University Teaching
Garment Manufacturing
Tissue Molding
Statistics
Science
Data Analysis
Solidworks
Materials Science
Cell Culture
Photoshop Elements
Tewl Measurements
Leadership
Grant Writing
Suturing
Tissue Engineering
Large Animal Studies
Publication Writing
Wound Care

Contact information

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Work email
j••••••••@nyulangone.org
Personal email
•••••@•••••.com
Direct dial
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Current company

NYU Langone Health

Hospitals and Health Care · 30K employees · New York, New York, United States

NYU Langone Health is a fully integrated health system that consistently achieves the best patient outcomes through a rigorous focus on quality that has resulted in some of the lowest mortality rates in the nation. Vizient, Inc., has ranked NYU Langone No. 1 out of 118 comprehensive academic medical centers across the nation for four years in a row, and U.S. News & World Report recently ranked four of its clinical specialties No. 1 in the nation. NYU Langone offers a comprehensive range of medical services with one high standard of care across seven inpatient locations, its Perlmutter Cancer Center, and more than 320 outpatient locations in the New York area and Florida. The system also includes two tuition-free medical schools, in Manhattan and on Long Island, and a vast research enterprise. For more information, go to nyulangone.org and interact with us on LinkedIn, Glassdoor, and Indeed. More: NYU Grossman School of Medicine has trained thousands of physicians and scientists who have helped to shape the course of medical history since 1841. With more than 75 divisions of specialty care including comprehensive inpatient and outpatient programs for every stage of life, a multifaceted Research and Academic Center and the NYU Grossman Long Island School of Medicine focused on primary care, NYU Langone Hospital-Long Island joined NYU Langone Health as of August 1, 2019. At NYU Langone Hospitals, NYU Grossman School of Medicine, NYU Grossman Long Island School of Medicine and NYU Langone Health (collectively referred to as "NYU Langone"), we work collectively to achieve our mission: To care. To teach. To discover. We celebrate the inclusive excellence of the people that make us a world-class institution in patient care, education and science ("tripartite missions"). We strive to be a place where our exceptionally talented faculty, staff and students can thrive.

nyulangone.org

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