Han Si
Regulatory Affairs Professional, led Class II K251753 submission
- Role
- Regulatory Affairs and Quality Assurance Specialist at Genabio Diagnostics
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Han Si
Successfully led K251753 and K240545 submission to clearance- Expertise in…
Experience
Regulatory Affairs and Quality Assurance Specialist
Jan 2024 — Present · Bedford, MA, US
Led the K25•••••10(k) submission and co-supported the K240545 submission, resulting in successful clearance. Writing submission documents including 510(k) summary, technical documents, labelling, analytical and clinical validation study reports, etc. Kept communication throughout the FDA reviewing process. • Led Q-sub with FDA for De Novo products, conducted market research and regulatory research, organized product technical information and translated the regulations into feasible actions, and led communications with FDA. • Managed clinical trials with 687 participants across 7 locations, ensuring on-time completion and regulation compliance, including IRB, site preparing, initiation, monitoring, close-out.• Secured Medicaid reimbursement approvals for diagnostic tests by successfully engaging state agencies and managing critical compendia such as First Databank, expanding patient accessibility and revenue opportunities.• Ensured compliance with FDA Establishment Registration, Device Listing, GUDID requirements, and FSA/HSA eligibility, enabling seamless market access. • Enhanced QMS compliance per ISO 13485:2016 through SOP updates, audits, and CAPA implementation.
Education
Northeastern University
Master of Science - MS, Regulatory Affairs
South Dakota State University
Bachelor of Science - BS, Dairy Manufacturing with Minor in Food Safety
2015 — 2019
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