Mark Tsai

About Mark Tsai

With over 20 plus years of combination products and surgical device experience, I offer device development in biopharmaceutical and medical device industries.Competencies* New Product Development and Technical Program Management: Product Concept to Commercialization* Drug Products: Cell Suspensions, Monoclonal Antibodies, Drug Suspensions, Silicone Oil for Ophthalmic Injection* Drug Delivery Platforms: intrathecal drug port/catheter system, Autoinjectors, Prefilled Syringes and subretinal microfluidic drug delivery* Device Industry: intrathecal, ophthalmic, cardiovascular surgical devices and cell-based drug delivery system* Device Types: single-use and reusable devices, implantables, combination products, Class II and devices* Risk Management Process per EN ISO 14971* Design Control (Design Input, Output, Design V&V, Transfer)* Human Factors Studies* Clinical Plan (Class II and Devices)* Clinical Evaluation (CER) Management

Experience

1. Associate Director, Combination Product Development

   Otsuka Pharmaceutical Companies (U.S.)

   Jun 2022 — Present · Princeton, NJ, US

Education

• University of California, Irvine - The Paul Merage School of Business

  M.B.A.

• University of California, San Diego

  B.S.

Skills

• Project Management
• Cer
• Ctms
• Clinical Trials
• R&D
• Ophthalmology
• Pharmaceutical Industry
• Sop
• Fda
• 21 Cfr Part 11
• Biotechnology
• Stem Cells
• Catheters
• Product Development
• Technology Transfer
• Design Control
• Regulatory Affairs
• Gcp
• Product Design
• Product Launch
• Design of Experiments
• Iso 13485
• Glp
• Quality System
• V&V
• Commercialization
• Clinical Development
• Drug Delivery
• Fda Gmp
• Biomedical Engineering
• Risk Management
• Regulatory Requirements
• Validation
• Testing
• Change Control
• Targeted Drug Delivery
• Regulatory Submissions
• Leadership
• Medical Devices
• Clinical Research