Ji-Eun Kim

Ji-Eun Kim

Director of Regulatory Affairs at Northwell Health
Lake Success, NY (USA)

RAC holder since 2018

 
 
 
 
 

How did you get into a regulatory career? What do you like about regulatory affairs?

I have a PhD in applied bioscience/biological engineering and have transitioned my career from science into healthcare. I have slowly expanded my role into regulatory affairs while serving as an institutional reviewer for new clinical research protocols and providing guidance in related-regulatory areas.

Currently, I oversee the regulatory affairs division in the compliance department of a NY-based large healthcare organization with 23 hospitals and more than 830 outpatient facilities. Our division provides regulatory consultation and guidance for translational research and development activities with FDA-regulatory products across our organization. In regulatory affairs, I need to and can learn about various new medical products and regulatory frameworks for bringing those products to market. The best part of my job is using what I have learned to help our researchers navigate regulatory pathways and requirements for their innovative ideas.

What was an especially memorable moment for you on the job?

A memorable moment for me was the first time a researcher consulted with me on regulatory pathways and requirements for a device he was developing. Since I did not have any previous hands-on experience in the medical device area, it was challenging to figure out a regulatory definition, classification and requirements for regulatory submissions, quality system regulation, and other applicable topics. Eventually, I was able to identify those requirements, and the FDA concurred with my assessment. That was one of the many baby steps toward competency in regulatory affairs for me.

How has the RAC aided you in performing your job?

Through my RAC exam preparation and access to useful resources via RAPS membership, I have learned and continue to learn both technical and general skills to be a regulatory professional and to lead a regulatory affairs team. Regulatory Affairs is a niche area in hospital-based healthcare organizations because hospitals and providers are typically consumers and users of commercial products rather than manufacturers or developers. Over time, regulatory affairs professionals within hospitals and higher-education institutions have demonstrated the value of in-house regulatory support for researchers and innovators. Their ideas stem from direct experiences with patients and real-world inputs from healthcare providers. Regulatory professionals can provide in-house regulatory strategies and support for researchers and healthcare providers throughout the feasibility, development, and post-market activities. The RAC has enabled me to gain regulatory knowledge, frameworks, and credibility, which have been essential in supporting our researchers.

How did you prepare for the RAC exam? What steps would you recommend to someone thinking about achieving certification?

I would recommend anyone considering the RAC first to check out the exam guides at the RAPS website, next to apply for an exam (devices and/or drugs), and then prepare with effective resources. The RAPS book Fundamentals of US Regulatory Affairs was the most important resource when I was preparing for the exam. I made my own notes for each chapter with supplements from other resources. I also took a RAC preparation course and used the practice exam from RAPS. I think these resources are essential and sufficient to prepare for the certification. Best of luck to everyone who is working towards certification!



 
 
View more stories