Includes creating and negotiating EUA, 510(k), PMA, HDE, CLIA, IDE, Q-Sub, IND, Pre-IND, BLA, ANDA, CE Mark Technical File/Dossier, Health Canada, and various other global regulatory submissions. Recently, she assisted the World Health Organization (WHO) as an Innovation COVID-19 Response Team Consultant and Operations Support & Logistics Supply Team Consultant, where she evaluated regulatory and quality system preparedness for COVID-19 medical devices and IVDs for WHO placement in under–served countries.
Includes GLP, GCP, cGMP, QSR, ISO 13485, ISO 14971, PAI, MDSAP, Australia TGA, Health Canada, and Japan MHLW audits.
Includes creating protocols, investigator brochures, clinical management procedures, conducting GCP audits, writing and negotiating Pre-INDs/IDEs, writing and negotiating INDs/IDEs, and writing and negotiating various pre-market submissions containing clinical data. She has participated in and/or managed the following types of clinical studies: IVDs, medical devices, biologics, pharmaceutical, and combination products. Kim has extensive negotiation experience with the FDA and other global regulatory authorities.
Kim participated on the UC Irvine Extension Life Science Advisory Committee for three years. Additionally, Kim guest lectured for the CSULA “From Concept to Market” BIOL 454L and UCSD “Regulatory Strategies for Combination Products with Medical Devices” courses. She participated on the CSUPERB Advisory Committee, Development Team for the Project Management in Clinical Trials Certificate Program through the California State University system. She was the instructor for the “Pre-Market Submission” course and co-instructor for the “Regulatory Requirements for Medical Products” course. Kim was also an instructor for the “Regulatory Requirements for Pharmaceutical Products” course and a co-instructor for the “Technical Writing for the Medical Product Industry” course at the University of California Irvine Extension. She also re-developed and currently teaches the “Medical Device Regulations” course for the San Diego State University (SDSU) Master of Science in Regulatory Affairs program. Kim developed and has taught since 2016 an undergraduate “Medical Product Regulations: Bench to Bedside” course at CSUF with a focus on stem cell therapies, through a California Institute for Regenerative Medicine (CIRM) grant program. She developed and taught the “Introduction to Regulatory Affairs” course at Roseman University’s College of Graduate Studies.
Kim has served on the Orange County Regulatory Affairs Discussion Group (OCRA) Program Committee since 2003. She taught at and managed the OCRA US RAC Study Group from 2004–2008 and the EU RAC Study Group 2004-2005. Kim was elected as the OCRA Annual Meeting Chair where she managed, moderated, and presented at the 2006 and 2007 2-day FDA-OCRA Annual Conferences with an average attendance of ~325 regulatory, quality, clinical, and government professionals. Additionally, she served on the OCRA Board of Directors 2004-2010 and 2019 and was the 2008-2009 President. Kim participated on the CLSI Point of Care Testing, Quality Systems, EP9, and Process Improvement working groups. She has managed, presented at and/or moderated at several professional conferences and educational institutions on clinical, regulatory, and quality topics. She also has participated in the SDRAN Mentoring Program since 2009.
Kim achieved both the US and EU Regulatory Affairs Professional Society (RAPS) Regulatory Affairs Certifications and has been accepted as a RAPS Fellow in recognition of her contributions and leadership in advancing the regulatory profession. Additionally, Kim received the 2008 Leonard Stauffer Award from RAPS in recognition of her contributions to mentoring and furthering regulatory professional education development. She received a Leveraging Collaboration Award from the FDA for being the industry originator of the LOS-DO Quality Leadership Network (QLN), helping to bridge communication and collaboration opportunities between FDA and industry. She was awarded a lifetime membership by OCRA in 2017 and SDRAN in 2022.
Kim has a Bachelor of Science degree in Bio-Medical Sciences and a Master of Science degree in Regulatory Affairs.