Team
Jin Kim
Sr. Project Manager
Jin brings over a decade of experience spanning the medical device, healthcare, and pharmaceutical industries. Her career has centered on guiding new products from concept to launch, with a focus on medical devices in highly regulated environments. She has led cross-functional teams through the complexities of product development, technology transfer, and commercialization, ensuring quality and compliance at every stage. Known for her collaborative leadership style and ability to keep programs moving in fast-paced settings, Jin combines strategic insight with a hands-on approach to problem solving. She is passionate about building processes and partnerships that help teams deliver innovative solutions to improve patient outcomes.
Academic & Professional Qualifications:
- B.S. in Pharmacological Chemistry, University of California San Diego
Training, Quality Systems, & Specialties:
- Medical Device Design and Development
- Program Management
- Design Controls
- FDA, 21 CFR Part 820 for Medical Devices; Quality System Regulations
- ISO 14971 Medical Devices – Risk Management
- EN ISO 13485 & ISO 13485 Medical Devices Quality Management Systems
- In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746