• Prepare and maintain international submission dossiers.• Prepare, compile and publish electronic pre-market and post-market regulatory submissions.• Compile Technical Documentations for IVD medical devices to support EU CE-Mark.• Interact with business partners to support ROW submissions for IVD medical devices (Asia Pacific, Latin America, Europe, the Middle East and Africa, Canada etc.).• Monitor progress on key project deliverables and provide status updates to management on a regular basis.• Support on-market regulatory activities and new product development core teams as assigned by management.• Manage relationships with international customers (e.g., regulatory agencies, distributors, etc.).• Demonstrate in-depth understanding of advanced technical/scientific principles related to MDR / IVDreagent chemistry, laboratory automation, and software components of MDR / IVD medical devices.• Communicate regulations to technical functions within the company.

• Prepare and submit new facility license/registration applications to relevant authorities in the US (e.g., FDA, CLIA, State DOH, PPTA, etc).• Track license/registration renewals. Submit renewals timely to ensure continuity in maintaining current.• Prepare and submit other regulatory submissions, applications, reports and notifications in a timely manner according to regulatory and company requirements.• Respond to regulatory agency(include BPD reports, PAS, SaMD), field locations and corporate department requests when required.• Review, evaluate, and communicate new and revised regulations.• Develop and manage regulatory project plans.• Represent Regulatory Affairs in project teams; provide regulatory advice.• Provide support, guidance, and coaching to other Regulatory Affairs team members.• Serve as direct liaison with relevant health authorities under the supervision of direct manager.

• Reviewed laws and regulations to ensure up to date compliance requirements.• Demonstrated workplace leadership by mentoring technicians and training new-hire staff in a fast-paced, team-oriented environment.• Communicated prior authorizations, clinical assessments, and copay assistance with physicians/patients.• Attended price negotiation meetings with AmerisourceBergen, Anda, and QK Healthcare.• Multitasked daily operations and outreach services such as patient follow-ups and adherence counseling.

• Initiated and furnished treatments per guidelines for patients with hypertension, T2DM, and dyslipidemia.

• Created and reviewed clinical presentation slides on Nuedexta patients with traumatic brain injuries (TBIs).• Discussed FDA regulatory guidances, Nuedexta’s package design, package insert, and marketing strategies with staff members at weekly/biweekly company regulatory compliance meetings.

• Presented clinical cases, topic discussions, and final APPE projects with preceptors, staff members and students.• Organized and computed quarterly Transition of Care (TOC) Program data to create a presentation for administrative review.

• Analyzed and reported on compounding logs, inventory control, and medication dispensing errors.• Conducted field research on upcoming new pharmacy laws and participating parties’ compliance status.• Participated in and compiled the clinical materials for pharmacy and therapeutics (P&T) committee meetings.

• Provided supervision, inventory management, regulatory compliance, and billing resolutions.• Implemented strategies to increase sales volume and revenue, which resulted in 15% increase QOQ.

• Assisted patients with appointments, medical insurance eligibility, medical billing, and translation services.

• Performed in-depth research on yeast cells with selected reagents. • Demonstrated proper laboratory techniques and procedures. • Analyzed the data and completed the research project through written and oral presentation.