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.

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Alex Chang, MS, RAC
Founder and Principal
  • Alex Chang, LinkedIN

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
  • 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 Alex

Consulting Projects

Allergan, Inc. (Pleasanton, CA) Sr. Manager, Regulatory Affairs


May 2018 - May 2019

  • Regulatory Affairs lead for the regulatory department with three direct reports
  • Supervised direct reports on global regulatory, labeling/translations, MDR/Complaints and Marketing Review (Ad/Promo)
  • Submitted a Traditional 510(k) claim expansion and a Special 510(k) for new hardware/software modifications and received clearance within 60 and 30 days, respectively.
  • Provide regulatory impact assessment on reportability for Change Order Requests
  • Co-regulatory lead for the Pleasanton facility in transitioning to the new EU MDR. Also received training for the EU MDR from Oriel-STAT.
  • Represented Regulatory during audits including MDSAP and Notified Body surveillance inspections.




Singulex, Inc. (Alameda, CA) Sr. Manager, Regulatory Affairs


April 2014 - May 2018

  • Regulatory representative in the Diagnostics, Clinical Lab, and Life Science business units of the company.
  • Overseen and maintained state licenses for the Singulex Clinical Laboratory which includes being the regulatory representative in all team projects for the lab and ensuring that the laboratory is in compliance with all applicable laws pertaining to the lab in California and in all other states where Singulex operates.
  • In collaboration with the Director of Customer Operations and Singulex Compliance Officer, responsible for creating a robust process to supervise over 50 phlebotomists across the US and to manage four Singulex Patient Service Centers for collecting patient’s specimens.
  • Collaborated with cross-functional team members in the development and commercialization of break-through diagnostics products. Responsibilities include submitting 510(k)s and creating Technical Files in order for the IVD products to be legally placed in the US and European markets.
  • Key support to the Quality Department in creating processes for Complaint Handling, Adverse Events Reporting (MDRs) and Post Marketing Surveillance. Also instrumental in creating procedures for the Quality System in accordance to FDA 21 CFR 820 and ISO 13485 which led to our company’s achieving the milestone of becoming ISO 13485 certified in 2016.
  • Led the risk management activities for the Diagnostics Project Team and took on responsibilities of managing the risk meetings, and generating the risk plans, usability plans, and risk reports required for regulatory filings.
  • Worked closely with Marketing to approve all marketing materials (adverts, sales materials, slide presentations product labeling, brochures, website content, videos, etc.) to ensure that all claims are truthful, non-misleading, and are fully supported by study data and publication.
  • Worked closely with Operations in developing processes for ensuring compliance with the RoHS and REACH Directive for Europe.
  • Implemented UDI (Unique Device Identifiers) to comply with the compulsory FDA requirements to include the UDI barcode in all IVD labeling. Also responsible for coordinating with our contract manufacturers in assigning Global Trade Item Number (GTIN) and maintaining the UDI database with FDA.
  • Provide semi-annual updates to executive management on new laws and regulations as well as the regulatory landscape for the following countries/regions: US, Europe, Canada, Brazil, China, and Australia, as part of the Dx Management Review.
  • Also certified as a ISO 13485:2016 Lead auditor from Oriel-STAT.




Novartis Diagnostics, Inc. (Emeryville, CA) Associate III, Regulatory Affairs


August 2011 - April 2014

  • Worked in both business units: blood testing unit and Nucleic Acid Testing (NAT) unit.
  • Collaborated with joint-partner Hologic (formerly Gen-Probe) as the Grifols Regulatory Affairs representative and provided regulatory advice for the IND submission of the Dengue Virus Assay Test.
  • Collaborated with joint-partner Ortho Clinical Diagnostics as the Novartis Regulatory representative in the development of the Ortho Clinical Diagnostic’s HIV Combo assay.
  • Involved with ROW registrations and renewals for blood testing and NAT products in APAC and EMEA regions. The product(s) and countries are listed below:
  • RIBA HCV 3.0 SIA and RIBA HIV-1/HIV-2 SIA: India, Indonesia, Singapore and Thailand.
  • Procleix Ultrio Elite Assay and Panther Instrument System: Indonesia, Russia, and Saudi Arabia.
  • Procleix Ultrio Plus Assay and Tigris Instrument System: Saudi Arabia.
  • Regulatory representative to the Cell Banking Improvement Team in the effort to streamline the current manufacturing process of licensed and unlicensed seedstocks.
  • Provided regulatory evaluations to CMC changes and submitted Annual Reports, CBE and CBE-30 to the FDA.
  • Submitted changes made to the existing DMFs to the FDA.




Celera Corporation (Alameda, CA) Manager, Regulatory Affairs


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

  • Successfully submitted Celera’s first PMA application, which has been accepted for FDA regulatory filing, while meeting an aggressive project timeline.
  • Regulatory liaison for the KIF6 Genotyping Assay PMA with the FDA.
  • Worked with senior management in providing regulatory strategies with a leading pharmaceutical company in the co-development of a companion diagnostics.
  • Successfully submitted a Medical Device License Application for Health Canada.​
  • Developed submission strategies and prepared submissions for domestic and international filings according to established timelines.
  • Prepared and submitted FDA 510(k) Pre-market Notification and prepared internal documentation for non-filing decisions for the following products: HIV-1 Genotyping System (ViroSeq) and Cystic Fibrosis Genotyping Assay
  • Prepared and submitted Design Dossier to the Notified Body for CE Marking.
  • Primary regulatory contact for Celera’s corporate partner in Rest of the World (ROW) registration filings.
  • Routinely provided Regulatory Intelligence and review current regulations, guidance, and external standards to ensure that the company is operating in compliance with the Quality Regulatory System.
  • Ensured that Celera products meet regulatory labeling requirements for IVD, RUO and ASRs.
  • Provided risk assessment and mitigation.
  • Provided regulatory guidance in labeling and promotional materials.
  • Established contact with FDA project managers and attended meetings with the FDA via teleconference.




IMPAX Laboratories, Inc. (Hayward, CA) Sr. Regulatory Affairs Associate


April 2003 - April 2007

  • Worked in both business units: Generic and Brand divisions.
  • Involved with the preparation and submission of three (3) Investigational New Drug Applications and one (1) New Drug Application.
  • Supported Global Clinical Trials by submitting an Investigational Medicinal Products Dossier (IMPD) for the Clinical Trials Authorization (CTA) application.
  • Have experience in Common Technical Documents (CTD) and played a key role in transitioning our department to CTD-format and Structured Product Labeling.
  • Reviewed Informed Consent Forms and Study Protocols for critical Brand Clinical Trials.
  • Instrumental in training and mentoring several regulatory affairs associates.
  • Acted as manager for several months and worked closely with the Vice President and Senior Director of Regulatory Affairs.
  • Lead author for fifteen (15) Abbreviated New Drug applications
  • Ensured regulatory compliance by maintaining and documenting adverse events and submitting annual reports for all 39 approved drug products
  • Responded to numerous deficiency letters sent out by the FDA in a timely manner
  • Have labeling and post-marketing experience.
  • Function as primary regulatory contact in the Product Launch meetings.
  • Experience in Drug Listing and submitting Promotional Materials to the agency.
  • Function as primary regulatory contact for product and adverse complaints.
  • Provided support to the legal department on litigation issues
  • Establish contact with FDA project managers and attend meetings with the FDA via teleconference.
  • Have 4 years of CMC experience




MedImmune Vaccines, Inc. (Santa Clara, CA) Research Associate II (Process Development)


January 2001 - April 2003

  • Drafted Standard Operation Procedures (SOPs) and Technical Reports for the Pilot Plant and Manufacturing departments
  • Involved with improving the manufacturing process of the nasal vaccine (FluMist®) for the influenza virus
  • Assisted lead scientists in genotyping the RNA segment of the influenza virus and performed numerous experiments to factor the best conditions in viral cultivation
  • Trained to work in a cGMP (current Good Manufacturing Process) environment





Professional Experience

Allergan, Inc. (Pleasanton, CA) Sr. Manager, Regulatory Affairs


May 2018 - May 2019

  • Regulatory Affairs lead for the regulatory department with three direct reports
  • Supervised direct reports on global regulatory, labeling/translations, MDR/Complaints and Marketing Review (Ad/Promo)
  • Submitted a Traditional 510(k) claim expansion and a Special 510(k) for new hardware/software modifications and received clearance within 60 and 30 days, respectively.
  • Provide regulatory impact assessment on reportability for Change Order Requests
  • Co-regulatory lead for the Pleasanton facility in transitioning to the new EU MDR. Also received training for the EU MDR from Oriel-STAT.
  • Represented Regulatory during audits including MDSAP and Notified Body surveillance inspections.




Singulex, Inc. (Alameda, CA) Sr. Manager, Regulatory Affairs


April 2014 - May 2018

  • Regulatory representative in the Diagnostics, Clinical Lab, and Life Science business units of the company.
  • Overseen and maintained state licenses for the Singulex Clinical Laboratory which includes being the regulatory representative in all team projects for the lab and ensuring that the laboratory is in compliance with all applicable laws pertaining to the lab in California and in all other states where Singulex operates.
  • In collaboration with the Director of Customer Operations and Singulex Compliance Officer, responsible for creating a robust process to supervise over 50 phlebotomists across the US and to manage four Singulex Patient Service Centers for collecting patient’s specimens.
  • Collaborated with cross-functional team members in the development and commercialization of break-through diagnostics products. Responsibilities include submitting 510(k)s and creating Technical Files in order for the IVD products to be legally placed in the US and European markets.
  • Key support to the Quality Department in creating processes for Complaint Handling, Adverse Events Reporting (MDRs) and Post Marketing Surveillance. Also instrumental in creating procedures for the Quality System in accordance to FDA 21 CFR 820 and ISO 13485 which led to our company’s achieving the milestone of becoming ISO 13485 certified in 2016.
  • Led the risk management activities for the Diagnostics Project Team and took on responsibilities of managing the risk meetings, and generating the risk plans, usability plans, and risk reports required for regulatory filings.
  • Worked closely with Marketing to approve all marketing materials (adverts, sales materials, slide presentations product labeling, brochures, website content, videos, etc.) to ensure that all claims are truthful, non-misleading, and are fully supported by study data and publication.
  • Worked closely with Operations in developing processes for ensuring compliance with the RoHS and REACH Directive for Europe.
  • Implemented UDI (Unique Device Identifiers) to comply with the compulsory FDA requirements to include the UDI barcode in all IVD labeling. Also responsible for coordinating with our contract manufacturers in assigning Global Trade Item Number (GTIN) and maintaining the UDI database with FDA.
  • Provide semi-annual updates to executive management on new laws and regulations as well as the regulatory landscape for the following countries/regions: US, Europe, Canada, Brazil, China, and Australia, as part of the Dx Management Review.
  • Also certified as a ISO 13485:2016 Lead auditor from Oriel-STAT.




Novartis Diagnostics, Inc. (Emeryville, CA) Associate III, Regulatory Affairs


August 2011 - April 2014

  • Worked in both business units: blood testing unit and Nucleic Acid Testing (NAT) unit.
  • Collaborated with joint-partner Hologic (formerly Gen-Probe) as the Grifols Regulatory Affairs representative and provided regulatory advice for the IND submission of the Dengue Virus Assay Test.
  • Collaborated with joint-partner Ortho Clinical Diagnostics as the Novartis Regulatory representative in the development of the Ortho Clinical Diagnostic’s HIV Combo assay.
  • Involved with ROW registrations and renewals for blood testing and NAT products in APAC and EMEA regions. The product(s) and countries are listed below:
  • RIBA HCV 3.0 SIA and RIBA HIV-1/HIV-2 SIA: India, Indonesia, Singapore and Thailand.
  • Procleix Ultrio Elite Assay and Panther Instrument System: Indonesia, Russia, and Saudi Arabia.
  • Procleix Ultrio Plus Assay and Tigris Instrument System: Saudi Arabia.
  • Regulatory representative to the Cell Banking Improvement Team in the effort to streamline the current manufacturing process of licensed and unlicensed seedstocks.
  • Provided regulatory evaluations to CMC changes and submitted Annual Reports, CBE and CBE-30 to the FDA.
  • Submitted changes made to the existing DMFs to the FDA.




Celera Corporation (Alameda, CA) Manager, Regulatory Affairs


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

  • Successfully submitted Celera’s first PMA application, which has been accepted for FDA regulatory filing, while meeting an aggressive project timeline.
  • Regulatory liaison for the KIF6 Genotyping Assay PMA with the FDA.
  • Worked with senior management in providing regulatory strategies with a leading pharmaceutical company in the co-development of a companion diagnostics.
  • Successfully submitted a Medical Device License Application for Health Canada.​
  • Developed submission strategies and prepared submissions for domestic and international filings according to established timelines.
  • Prepared and submitted FDA 510(k) Pre-market Notification and prepared internal documentation for non-filing decisions for the following products: HIV-1 Genotyping System (ViroSeq) and Cystic Fibrosis Genotyping Assay
  • Prepared and submitted Design Dossier to the Notified Body for CE Marking.
  • Primary regulatory contact for Celera’s corporate partner in Rest of the World (ROW) registration filings.
  • Routinely provided Regulatory Intelligence and review current regulations, guidance, and external standards to ensure that the company is operating in compliance with the Quality Regulatory System.
  • Ensured that Celera products meet regulatory labeling requirements for IVD, RUO and ASRs.
  • Provided risk assessment and mitigation.
  • Provided regulatory guidance in labeling and promotional materials.
  • Established contact with FDA project managers and attended meetings with the FDA via teleconference.




IMPAX Laboratories, Inc. (Hayward, CA) Sr. Regulatory Affairs Associate


April 2003 - April 2007

  • Worked in both business units: Generic and Brand divisions.
  • Involved with the preparation and submission of three (3) Investigational New Drug Applications and one (1) New Drug Application.
  • Supported Global Clinical Trials by submitting an Investigational Medicinal Products Dossier (IMPD) for the Clinical Trials Authorization (CTA) application.
  • Have experience in Common Technical Documents (CTD) and played a key role in transitioning our department to CTD-format and Structured Product Labeling.
  • Reviewed Informed Consent Forms and Study Protocols for critical Brand Clinical Trials.
  • Instrumental in training and mentoring several regulatory affairs associates.
  • Acted as manager for several months and worked closely with the Vice President and Senior Director of Regulatory Affairs.
  • Lead author for fifteen (15) Abbreviated New Drug applications
  • Ensured regulatory compliance by maintaining and documenting adverse events and submitting annual reports for all 39 approved drug products
  • Responded to numerous deficiency letters sent out by the FDA in a timely manner
  • Have labeling and post-marketing experience.
  • Function as primary regulatory contact in the Product Launch meetings.
  • Experience in Drug Listing and submitting Promotional Materials to the agency.
  • Function as primary regulatory contact for product and adverse complaints.
  • Provided support to the legal department on litigation issues
  • Establish contact with FDA project managers and attend meetings with the FDA via teleconference.
  • Have 4 years of CMC experience




MedImmune Vaccines, Inc. (Santa Clara, CA) Research Associate II (Process Development)


January 2001 - April 2003

  • Drafted Standard Operation Procedures (SOPs) and Technical Reports for the Pilot Plant and Manufacturing departments
  • Involved with improving the manufacturing process of the nasal vaccine (FluMist®) for the influenza virus
  • Assisted lead scientists in genotyping the RNA segment of the influenza virus and performed numerous experiments to factor the best conditions in viral cultivation
  • Trained to work in a cGMP (current Good Manufacturing Process) environment





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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