プロフィール詳細

プロジェクトを作成

★★★★★

☆☆☆☆☆

★★★★★

☆☆☆☆☆

Minh Tuan T.に依頼

United States

High-achieving individual with 4+ years in medical device regulations (EUMDR & FDA) and business process development.

プロフィール概要

Regulatory and Clinical Affairs Maintained strong customer relations, providing exceptional on-site technical, clinical, and sales support to over 100 clients. Delivered clinician education for 22 marketed product lines, increasing usage by 20%. Spearheaded IRB approval for two clinical trials and supported two live EUMDR audits. Drafted 60+ EUMDR regulatory documents for 22+ medical product lines. Documents include (a clinical development plan, clinical evaluation plan, clinical evaluation report, post-market surveillance plan, post-market clinical follow-up study, and summary of safety and clinical performance.) Technical and Clinical Support Supported 90+ surgical implant cases and endovenous laser ablation procedures. Hosted workshops that improved the department workflow process by 50%. Assisted in post-op wound cleaning and 30+ cosmetic procedures. drafted 15+ clinical study protocols that adhere to ISO 14155 and CFR 21 Part 11. Research and Development Researched and designed an all-in-one COVID RT-LAMP diagnostic device that operates without a battery. Led 4-man clinical research for a colorectal cancer diagnostic device, achieving 90% sensitivity and specificity. Created "TruSTD," an award-winning, user-friendly app designed for integration with dating platforms to raise awareness and prevent the spread of STDs. Product Management Conducted over 10 Voice of Customer (VoC) surveys, enhancing customer service and product design by 30%. Managed the clinical affairs department with a $200k budget, supporting 4+ new product developments. Created purchase incentives, resulting in a 24% increase in product sales within a month. Oversaw 6+ clinical studies and managed over 100 clinical cases successfully. Additional Skills Proficient in MS Office and Voice of Customer survey analysis. Fluent in English and Vietnamese. Knowledgeable in human anatomy, medical terminology, and business strategy.

専門分野

• ★ Medical Implants
• ★ European Medical Device Regulation (MDR)
• ★ Clinical Trials
• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Marketing
• ☆ Medical Device Development
• ☆ Medical Device Design
• ☆ Medical Device Prototyping
• ☆ ISO 13485
• ☆ Regulatory Affairs
• ☆ Product Evaluation
• ☆ Packaging Design
• ☆ Skills Training
• ☆ Crisis Management & Emergency Preparedness
• ☆ Project Management
• ☆ Risk Management
• ☆ Management Consulting

サービス

• Writing
• Research
• Consulting
• Product Development

Writing Non-Medical Regulatory Writing

Research User Research

Consulting Business Strategy Consulting, Operations Consulting, Regulatory Consulting

Product Development Product Evaluation, Product Compliance , Concept Development, Packaging Design, Prototyping

職務経験

Clinical Account Specialist

Intera Oncology

1月 2024 - 現在

Clinical and Regulatory Affairs Specialist

Ormco

7月 2021 - 1月 2024

Graduate Researcher

Keck Graduate Institute

8月 2019 - 5月 2021

Medical Assistant and Office Administrator

Foothill Varicose Vein Clinic

1月 2018 - 1月 2020

Health Coach

San Antonio Regional Hospital

12月 2016 - 12月 2017

Research Assistant - Research Associate

Western University

2月 2016 - 8月 2016

学歴

Masters of Science

Keck Graduate Institute

8月 2019 - 5月 2021

Bachelor of Science

California Polytechnic State University, Pomona - United States

8月 2013 - 6月 2018

認定資格

• Business Analysis Foundation

  LinkedIn

  https://www.linkedin.com/learning/certificates/c40849e21c1142d02244b29d55a9fb6914da1f97e9d7661e7c04f681d14d5b2a?trk=backfilled_certificate

  1月 2024 - 現在

• Excel Data Visualization: Mastering 20 plus Charts and Graphs

  LinkedIn

  https://www.linkedin.com/learning/certificates/d624c3059cc89e1d36de90db080576471b92995a339e826d3d53997829bd8e50?trk=backfilled_certificate

  1月 2024 - 現在

• SAP ERP Essential Training

  LinkedIn

  https://www.linkedin.com/learning/certificates/b2b500387c8629f374e42940d25d8be08c59cbd1d5cd50ea005b25faadcff35c?trk=backfilled_certificate

  1月 2024 - 現在

• Problem Solving Process

  Envista Corporation

  1月 2024 - 現在

• Voice of Customer Survey Generation and Effectiveness

  Envista Corporation

  1月 2024 - 現在