Trang Huynh

About Trang Huynh

Accomplished regulatory affairs and quality assurance professional with extensive experience in the medical device and biotechnology sectors. Expertise in navigating complex regulatory frameworks, leading cross-functional teams, and achieving successful product launches and certifications. Proven track record in streamlining processes, managing risk, and enhancing quality management systems. Skilled at building collaborative relationships and ensuring alignment with business objectives. My strategic mindset and hands-on leadership style position me for success in managerial roles, driving impactful outcomes in highly regulated environments.

Experience

1. Regulatory Affairs Manager

   Philips

   Sep 2021 — Present · US

   Directed Regulatory Affairs team to enhance resource management and streamline project allocations.• Guided cross-functional teams in crafting responses to FDA for multiple FDA clearances.• Spearheaded audit preparations and compliance initiatives to secure new certifications for a new facility.• Collaborated with Bodies to facilitate timely new EU MDR certifications and strategic change notifications.

Education

• Salve Regina University

  BS, Chemistry & Mathematics

• UC San Diego

  MS, Physical Organic Chemistry

Skills

• Spc
• Cqe
• Product Development
• Fmea
• Minitab
• Biomedical Engineering
• Cross-Functional Team Leadership
• Supplier Quality
• Iso 14971
• Quality Control
• Gmp
• Cgmp
• R&D
• Root Cause Analysis
• Iso
• Sop
• Fda
• 21 Cfr
• Medical Devices
• Capa
• Nmr
• Validation
• Design Control
• 21 Cfr Part 11
• Quality Management
• Dmaic
• Manufacturing Engineering
• Quality System
• V&V
• Hplc
• Six Sigma
• Regulatory Affairs
• Quality Auditing
• Chemistry
• Process Capability
• Chromatography
• Lean Manufacturing
• Fda Gmp
• Design for Manufacturing
• Quality Assurance