© 2019 by BioDesign Regulatory Services, LLC

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 Me

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.

Noteable Skills:
  • ISO 13485:2016 Certified Lead Auditor
  • MDSAP
  • EU MDR and MDD
  • IVDR and IVDD
  • Regulatory Submissions - Domestic and Global 

Click the arrow keys below to learn more about me

Consulting Projects

*Client's name is hidden for confidentiality.  Please click the arrow button to expand individual items.  

Client: A Diagnostic Company (August 2019 - current)
Role: IVDD - IVDR Transition 
Client: A Medical Aesthetics Device Company   (June 2019-current)
Role: 510(k) submissions
Client: A Diagnostic Company  (May 2019-July 2019)
Role: EU Technical File
 

Client: CMO of Pharmaceutical Products  (May 2018-current)
Role: US-Agent

 

Client: A Diagnostic Company  (May 2018 - November 2018)

Role: CLIA - Regulatory

 

Professional Experience

*Please click the arrow button to expand individual items.  

Allergan, Inc.  (Pleasanton, CA) 

Sr. Manager, Regulatory Affairs

May 2018 - May 2019

Singulex, Inc. (Alameda, CA)

Sr. Manager, Regulatory Affairs

April 2014 - May 2018

Novartis Diagnostics, Inc. (Emeryville, CA)

Associate III, Regulatory Affairs
August 2011 - April 2014

Celera Corporation (Alameda, CA)

Manager, Regulatory Affairs (March 2011 - August 2011)

Sr. Regulatory Affairs Specialist (April 2007 - March 2011)

IMPAX Laboratories, Inc. (Hayward, CA)

Sr. Regulatory Affairs Associate

April 2003 - April 2007

MedImmune Vaccines, Inc.  (Santa Clara, CA)

Research Associate II (Process Development)

January 2001 - April 2003

Education

Universities

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Santa Clara University (Santa Clara, California) 
Masters of Business Administration – Concentration: Data Science and Business Analytics (Currently pursuing. 2017-present.)

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Northeastern University (Boston, Massachusetts) 

Masters of Science in Regulatory Affairs (2009-2011)

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Florida International University (Miami, Florida)

Bachelor of Science in Biological Sciences, 1999

Certifications

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EU MDR Transition Training Certificate of Completion

ORIEL-STAT A MATRIX, October 2018

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ISO 13485:2016 Certified Lead Auditor

ORIEL-STAT A MATRIX, March 2018

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Regulatory Affairs Certification (RAC) - US

Regulatory Affairs Professional Society, Spring 2007

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 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:

  • "The Cost of Personalized Medicine"; Speaker: Dr. Steven Gutman, M.D.

  • "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:

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