Jiyoung Morgan Dang
Associate Director Regulatory Affairs at Abbott | Former US FDA
- Role
- Associate Director Regulatory Affairs at Abbott
- Location
- Santa Clara, CA, US
- LinkedIn followers
- 500 followers
About Jiyoung Morgan Dang
Agile and versatile leader in medical device regulation with 18+ years professional experience• Former FDA leader in premarket regulation of medical devices and combination products• Strategic, results-oriented, data-driven decision-maker with experience working in highly matrixed, complex, and uncertain environments• Influencing and collaborating across multi-disciplinary, cross-functional, and cross-business teams• Extensive experience working with regulatory agencies and notified bodies (FDA, BSI, TÜV SÜD)• Experienced leader in talent development to build and manage high-functioning teams• Expertise with technical and clinical evaluation of medical devices across a wide range of disciplines, including plastic and reconstructive surgery, wound and burn care, orthopedic, and cardiovascular• Extensive experience with quality systems, risk management, and change management
Experience
Associate Director Regulatory Affairs
Jan 2022 — Present · Santa Clara, CA, US
Manage team of regulatory specialists and support endovascular product portfolio. Interface and negotiate with regulatory agencies to achieve approvals and support business growth. Provide regulatory strategy and US and EU submissions support for new product development and sustaining projects. Provide support for international regulatory programs.
Education
The Johns Hopkins University
B.S., Biomedical Engineering
1996 — 2000
The Johns Hopkins University School of Medicine
Ph.D., Biomedical Engineering
2000 — 2006
Skills
- Regulatory Affairs
- Lifesciences
- Orthopedic
- Healthcare
- Science
- Biochemistry
- Biomaterials
- Surgery
- U.s. Food and Drug Administration (Fda)
- Tissue Engineering
- Fda
- Life Sciences
- Clinical Development
- Stem Cells
- Clinical Trials
- Medical Devices
- Pharmacology
- Biomedical Engineering
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