Fang Zhang
Carlsbad,CA
Summary
Licensed attorney and pharmacist with regulatory experience in the medical device, biotechnology and pharmaceutical industries.
Overview
15
15
years of professional experience
Work History
Senior Regulatory Affairs Specialist
Synaptic Medical Corporation
Carlsbad, CA
07.2022 - Current
- Participate in establishing the regulatory department at the start-up (creating and revising standard operation procedures and work instructions)
- Participated in EU MDR audit
- Reviewed CAPA and non-conformance
- Mentored specialists for EU MDR design dossier submissions
- Participated in the design, budget, contracting and implementation of pre-clinical, first-in human, investigational device exemption studies, and global clinical trials
- Authored (US and EU) and participated (Japan and China) in new product market approval, and represented the company during communications with global regulatory agencies
Regulatory Affairs Specialist
Medtronics, Inc.
Irvine, CA
09.2020 - 07.2022
- Authored Class III medical device design change submission to the FDA
- Served as the regulatory subject matter expert for a neurovascular implant portfolio
- Led manufacturing site transfer from the U.S. to Mexico
- Authored EU MDR technical documentation
- Assessed design and manufacturing changes to ensure quality control
Regulatory Affairs Specialist
Medtronics, Inc.
Boulder, CO
04.2019 - 06.2020
- Supported global regulatory submissions of ventilators at the beginning of the COVID-19 pandemic
- Reviewed advertising and promotional materials for respiratory products
- Assessed product design and manufacturing changes to ensure quality control
Senior Principal Field Clinical Scientist
Medtronics, Inc.
Los Angeles, CA
09.2013 - 04.2019
- Conducted surgeon and research staff trainings for investigational device exemption (IDE) studies, and supported IDE cases in the operating room to ensure patient safety and good documentation practice
- Educated internal stakeholders on field competitive intelligence, and the latest clinical literatures
- Reviewed clinical evaluation reports
- Simultaneously managed several complex projects, meeting all pertinent milestones.
- Contributed to clinical trial design and statistical analysis
- Supported insurance claims based on scientific data
- Advised or assisted in obtaining patents or meeting other legal requirements.
- Led scientific advisory board
Medical Science Liaison
Questcor
Seattle, WA
08.2012 - 08.2013
- Educated internal stakeholders on orphan drug and rare disease competitive intelligence from external stakeholder interactions, medical congress and clinical literature
- Ensured timely and accurate adverse events reporting to the regulatory agencies
- Implemented pre-clinical research projects to facilitate development new treatment options for end-stage renal disease
Senior Medical Science Liaison
Johnson & Johnson, Janssen Pharmaceuticals
Seattle, WA
08.2007 - 08.2012
- Fulfilled unmet clinicians' needs for infectious disease, cardiology and pain management
- Informed internal stakeholders on field intelligence from scientific exchange with physicians and medical congress
- Assessed intellectual properties acquisitions
- Reported adverse reactions to the regulatory authorities
- Provided educational resources healthcare professionals and patients
- Trained physician speakers
- Contributed to clinical publications
- Reviewed advertising and promotional materials
Education
J.D. - Seattle University 2010
PharmD - University of Minnesota 2002
Licenses and Certifications
- Attorney License (Washington State Bar Association)
- Pharmacist License (Wisconsin Department of Health Services)
- ISO 13485 Lead Auditor Certificate (British Standards Institution)
- EU MDR Internal Auditor Certificate (Oriel STAT A Matrix)
Languages
English
Native or Bilingual
Chinese (Mandarin)
Native or Bilingual
Timeline
Senior Regulatory Affairs Specialist
Synaptic Medical Corporation
07.2022 - Current
Regulatory Affairs Specialist
Medtronics, Inc.
09.2020 - 07.2022
Regulatory Affairs Specialist
Medtronics, Inc.
04.2019 - 06.2020
Senior Principal Field Clinical Scientist
Medtronics, Inc.
09.2013 - 04.2019
Medical Science Liaison
Questcor
08.2012 - 08.2013
Senior Medical Science Liaison
Johnson & Johnson, Janssen Pharmaceuticals
08.2007 - 08.2012
J.D. - Seattle University 2010
PharmD - University of Minnesota 2002
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