ABOUT
Founded in 2018, BioDesign Regulatory Services, LLC is currently managed and operated by sole proprietor and principal consultant, Alex Chang. BioDesign specializes in regulatory submissions and regulatory services in the medical device and diagnostics industries but will soon expand to other areas as we grow our team.
Snapshot About Alex
I have been a great many things in my career in Regulatory Affairs: a student, a mentor, and a leader. I have worked in companies large and small, have been exposed to the medical device, diagnostics, pharmaceuticals and biologics industries and have submitted numerous submissions domestically and globally. When asked what I really enjoy most about my job is the diversity. I enjoy the diversity of working with different companies that are in the cusp of developing innovative medical products.
I am a life-long student and will humbly admit that despite my educational courseworks and practical work experiences, there is always much to learn. My interests are in personalized medicine and predictive health that stems from advanced diagnostic technology, digital health, and data analysis tools. I am well-rounded in the Quality Management System as well and have prepared companies for MDSAP in addition to the upcoming EU MDR and EU IVDR.
Notable Skills
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ISO 13485:2016 Certified Lead Auditor
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MDSAP
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EU MDR and MDD
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IVDR and IVDD
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Regulatory Submissions - Domestic and Global
Click the arrow keys below to learn more about Alex
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Client: A Diagnostic Company(August 2019 - current) Role: IVDD - IVDR Transition Provide regulatory expertise in preparing the company to transition to the new EU IVDR. Responsibilities include: providing company training, perform a gap assessment of the QMS to the new regulations and updating the EU Technical Documentation.
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Client: A Medical Aesthetics Device Company(June 2019-current) Role: 510(k) submissions Provided input to the company's response to FDA's 510(k) deficiency letter. Current project is the submittal of a Special 510(k).
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Client: A Diagnostic Company(May 2019-July 2019) Role: EU Technical File Coordinated in the creation and the filing of a Technical File for EU self-certification consisting of assay, instrument and software components.
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Client: CMO of Pharmaceutical Products(May 2018-current) Role: US-Agent US Agent for a Taiwanese-based CMO for pharmaceuticals. Instrumental in identifying to the client of their obligations as a CMO to list their products with FDA, which they are now compliant.
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Client: A Diagnostic Company(May 2018 - November 2018) Role: CLIA - Regulatory Provided regulatory support for a large diagnostic company in registering their clinical (CLIA) laboratory in Texas.
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Client: A Diagnostic Company(August 2019 - current) Role: IVDD - IVDR Transition Provide regulatory expertise in preparing the company to transition to the new EU IVDR. Responsibilities include: providing company training, perform a gap assessment of the QMS to the new regulations and updating the EU Technical Documentation.
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Client: A Medical Aesthetics Device Company(June 2019-current) Role: 510(k) submissions Provided input to the company's response to FDA's 510(k) deficiency letter. Current project is the submittal of a Special 510(k).
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Client: A Diagnostic Company(May 2019-July 2019) Role: EU Technical File Coordinated in the creation and the filing of a Technical File for EU self-certification consisting of assay, instrument and software components.
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Client: CMO of Pharmaceutical Products(May 2018-current) Role: US-Agent US Agent for a Taiwanese-based CMO for pharmaceuticals. Instrumental in identifying to the client of their obligations as a CMO to list their products with FDA, which they are now compliant.
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Client: A Diagnostic Company(May 2018 - November 2018) Role: CLIA - Regulatory Provided regulatory support for a large diagnostic company in registering their clinical (CLIA) laboratory in Texas.
Education
Universities
Santa Clara University (Santa Clara, California)
Masters of Business Administration – Concentration: Data Science and Business Analytics (Currently pursuing. 2017-present.)
Northeastern University (Boston, Massachusetts)
Masters of Science in Regulatory Affairs (2009-2011)
Florida International University (Miami, Florida)
Bachelor of Science in Biological Sciences, 1999
Certifications
EU MDR Transition Training Certificate of Completion
ORIEL-STAT A MATRIX, October 2018
ISO 13485:2016 Certified Lead Auditor
ORIEL-STAT A MATRIX, March 2018
Regulatory Affairs Certification (RAC) - US
Regulatory Affairs Professional Society, Spring 2007
Advanced Certificate in Regulatory Affairs
San Diego State University, August 2007
Community Activities
As Speaker/ Presenter
RAPS RAC Study Group - Topic: "IVD Regulations", August 2015
RAPS RAC Study Group (hosted by Varian Medical Systems) - Topic: "Generic Drugs Regulations", August 2007
RAPS SF Chapter Event - Topic: "How to Start Your Regulatory Consulting Business"
As Host and RAPS Chapter Leader
RAPS SF Chapter: "Recent Bioequivalence Studies with CMC Implications for Pre- and Postapproval Changes for Drugs and Biologics"; Speaker: Dr. James E. Polli, PhD, University of Maryland, April 2017
RAPS 2016 Convergence:
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"The Cost of Personalized Medicine"; Speaker: Dr. Steven Gutman, M.D.
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"US Regulatory Guidelines and Guidances for NGS Onco Panel Approval and Reimbursement"; Speaker: Dr. Federico Goodsaid, PhD.
RAPS SF Chapter Leader - Program Chair and Educational Chair (2013-2017)
PROUD MEMBER OF
