Alex Chang, Ms, Mba, Rac Email & Phone Number

Stealth SaaS company

Oakland, California, US

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.

San Francisco, CA, US

Provide advice and mentorship to start-ups that are part of the incubator program in matters pertaining to medical device and diagnostics.

San Jose, CA, US

Regulatory consultant for IVD and Medical Device companies focused in Precision Medicine and Digital Health. My passion is to help early startups and small companies develop strategies in regulatory and QMS to help launch their products.

www.zenbiomed.comManages the operations of the business. ZenBiomed, Inc. is a specialty Consulting firm that provides high-value services and staffing solutions to corporate clients in Life Sciences, primarily in Medical Device, IVD, Digital Health and Biologics/Biotech industry. Our areas of expertise include Regulatory Affairs, Medical Writing, Quality.

Fremont, California, US

Venture Partner and investor in Digital Health.

Alameda, CA, US

Regulatory head in a contract basis under Biodesign; provides regulatory strategies and manages the regulatory department. Involved with EU, UK and Global Expansion of Alveo products. Alveo develops a unique diagnostic device for the detection of SARS COV-2 virus utilizing Loop Mediated Isothermal Amplification (LAMP) based technology.

Fremont, California, US

- Evaluate digital health and medical device startup companies as potential investments- Provide regulatory advice to startups in navigating the regulatory hurdles in getting a medical device approved for market.

Cupertino, California, US

Contract role in International Regulatory Affairs and involved in the global expansion of SaMD device.

Dublin, Coolock, IE

Regulatory Affairs lead for the regulatory department with three direct reports on global and domestic regulatory and labeling/ translations. Successfully achieved FDA regulatory clearances for Allergan's medical aesthetic device, CoolSculpting and represented Regulatory Affairs for MDSAP audits and helping the company transition to the upcoming EU MDR.

- Regulatory representative for all three business units: Diagnostics, Clinical Laboratory, and Life Science- Regulatory lead as a Department of One for two years which led to the company's first CE-marking of the cTnI assay and Clarity instrument and the company's first 510(k) submission.- Key support to the Quality Department in creating processes for.

Basel, Baselstadt, CH

- 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.

- Successfully submitted Celera’s first PMA application, which has been accepted for FDA regulatory filing, while meeting an aggressive project timeline.- Worked with senior management in providing regulatory strategies with a leading pharmaceutical company in the co-development of a companion diagnostics.- Prepared and submitted FDA 510(k) Pre-market.

Hayward, CA, US

- 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.

Gaithersburg, Maryland, US

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

Waltham, MA, US

manufactured oligos (synthetic DNA) for research use. System Engineer for the ABI 3900 instrument, a high-throughput platform that synthesizes DNA oligonucleotides with rapid cycle times.

Master Of Business Administration - Mba, Entrepreneurial And Small Business Operations

Masters Of Science, Regulatory Affairs

Bachelor Of Science, Biological Sciences