Chin C.

Regulatory Affairs Associate @ Abbott

Country

United States

City

Los Angeles

Industry

Medical Device

Skill

Regulatory Affairs, Biomedical Engineering, Medical Devices, 生物科技, 生物醫學工程, 神經科學, Machine Learning, Neuroscience, Internal Audit, Quality Assurance, Regulatory Submissions, Project Management, 510k

Experience

Regulatory Affairs Associate

Abbott

2020-9 - Present · 6 yrs 1 mo

Santa Clara, California, United States

• Performed international submission activities, product registration/renewal, technical file update, etc. • Conducted gap assessments regarding product technical requirements for Korea and China • Conducted Change Order (CO), Change Request (CR) RA impact assessment

Regulatory affairs and Quality Assurance intern

Prescient Imaging, LLC

2020-5 - 2020-9 · 5 mos

Los Angeles, California, United States

• Assisted a 510k submission for a Class II medical device • Assisted a submission of Emergency Use Authorization (EUA) request

Consulting Services Specialist

International Center for Regulatory Science, USC

2019-8 - 2020-9 · 1 yr 2 mos

Los Angeles, CA

• Team lead of an MDSAP internal audit for a Class I medical device • Team lead of a pre-submission for a Class II medical device • Team lead of a product code and predicate device consultation for a 510k submission • Summarized information of the latest revision of Pharmaceutical Administration Law of China • Submitted an orphan drug designation request • Preparation for an IND submission • Submitted an INTERACT meeting submission for a gene therapy product

Research Assistant

Brain-Machine Interface Lab, NYMU

2019-1 - 2019-7 · 7 mos

Taipei City, Taiwan

• Set up a Taiwan Accreditation Foundation (TAF) certified laboratory for wearable device testing • Tested and adjusted the hardware of the wearable devices • Collected and analyzed first-hand data for stroke rehabilitation • Built the blood pressure evaluation model with wearable device data