Alex Chang

About Alex Chang

Alex is a regulatory affairs enthusiast and an entrepreneur with a passion for bringing innovative, life-saving products into the market. He has worked for over 20+ companies in a full-time or consultant role, in the medical device, diagnostics, pharmaceuticals and biologics sectors. Alex specializes in Regulatory Affairs and Quality and has taken on leadership roles as the head of the regulatory department for a few companies and was instrumental in providing strategic advice to the Executive Management Team in getting products into the market. Alex has founded his own consulting company, BioDesign Regulatory Services, Inc. in 2018. In the capacity of a consultant or contractor, Alex worked for large companies such as Apple and Thermo Fisher along with several dozen start-ups and midsize companies where he offered his expertise in areas of SaMD, IVDs, neurovascular devices, etc. and have recently entered into the Tech and consumer products sectors. He recently co-founded ZenBiomed, Inc, a staffing and consulting agency which provides offerings beyond those of BioDesign, where we focus on recruiting/staffing and offer services such as:(1) Medical Writing,(2) Auditing and (3) QMS implementation.Alex is also a community leader at the Regulatory Affairs Professional Society (RAPS) from 20••••18, spearheading chapter events and RAC-training courses. He functioned as a valuable mentor for many RAPS-constituents and continues to offer his time to the community.Alex is a former investor as an angel partner for CG Angels and is a Limited Partner for the Venture Fund: CHAP Health, formed in 2022. Alex holds a bachelor’s degree in Biological Science at Florida International University, a master’s degree in Regulatory Affairs at Northeastern University and an MBA at Santa Clara University.[Alex]: After 20+ years in my profession, I believe that I am now in the crossroads where all my interests intersect. I find that I can make the most impact professionally as a consultant where I not only focus on one product per company, but a variety of medical products among all sectors of the healthcare industry. I also find that I can make the most impact by being a strategic investor for healthcare companies by providing not just capital, but my operations expertise as I help then through their Seed to Series stages. In addition, I feel a sense of social impact and giving back during my community work with RAPS and provided mentorship as a Northeastern University alum and for the start-up accelerator: Nex Cubed.

Experience

1. Regulatory Advisor

   Koya Medical, Inc.

   Feb 2020 — Present

   Regulatory head; provides regulatory strategies and manages the regulatory department. Koya Medical manufactures an active wearable compression garment for the treatment of lymphedema while allowing patients with the mobility to move around.

Education

• Santa Clara University Leavey School of Business

  Master of Business Administration - MBA, Entrepreneurial and Small Business Operations

  2017 — 2020

• Florida International University

  Bachelor of Science, Biological Sciences

  1999

• Northeastern University

  Masters of Science, Regulatory Affairs

  2009 — 2011

Skills

• Vaccines
• Design Control
• Gmp
• Pharmaceutical Industry
• Fda
• Assay Development
• Life Sciences
• Regulatory Affairs
• Quality System
• Glp
• Pma
• Biotechnology
• Medical Devices
• Clinical Research
• Capa
• Clinical Development
• 21 Cfr Part 11
• Nda
• Drug Development
• Biopharmaceuticals