Sean Song
Regulatory Affairs | Punctual Project Executor | Expeditious Task Prioritizer |
- Role
- Regulatory Affairs Manager at Hydrafacial
- Location
- La Habra, CA, US
- LinkedIn followers
- 500 followers
About Sean Song
As a Regulatory Affairs, I have been working in the IVD (In-Vitro Diagnostic) and the MD (medical device) industry for 11+ years. I started my career working with scientists who helped me understand the FDA regulations. I had a curiosity and passion in biological sciences, which drove me to formulate an MFR (Master Formulation Record) of a clinical chemistry reagent and took it to the market in 2017 (Class II 510k Clearance). Designing and creating a product within FDA regulations was challenging; however, my sweat and effort turned into a strong knowledge that allowed me to continue to work in the regulatory science field. I have worked on 150+ international registrations with each revenue forecast ranging from $1.0k-$2.5M, and I received 200+ approved registration certificates from 50+ ROW countries. Followings are the countries/regions that I have expertise in medical device regulations:• United States• APAC• ASEAN• EMEA• LATAM• Non-EU countriesI like to work in new environments and enjoy taking challenges as learning opportunities to improve my skillsets that I have not discovered or obtained in the past. If you are interested in hearing more about me, please contact me.
Experience
Regulatory Affairs Manager
Jun 2024 — Present · Long Beach, CA, US
Education
UCLA
Bachelor's Degree, Biochemistry
California State Polytechnic University-Pomona
Master's Degree, Applied Biotechnology
2014 — 2016
University of Florida - Warrington College of Business
Master of Business Administration - MBA
2019 — 2021
Fullerton College
Biology/Biological Sciences, General
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