Mary Smith
Quality, Regulatory and Clinical Consulting at Freelance | San Francisco Bay Area
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Mary Smith is a seasoned Senior Regulatory Strategist with a wealth of experience in navigating the complexities of emerging fields such as combination products, digital health, machine learning, and precision medicine. Currently operating as a freelance consultant, Mary specializes in providing strategic insights to early-stage organizations, helping them establish robust regulatory, clinical, and quality frameworks essential for their growth and compliance. Her expertise is particularly valuable in areas where regulation is still evolving, allowing her to guide clients through the intricacies of regulatory submissions and quality management systems tailored for start-up environments.
In her role, Mary is actively involved in clinical trial oversight and operations, particularly in the development of in vitro diagnostics. She leverages her deep understanding of Good Manufacturing Practices (GMP), Good Clinical Practices (GxP), and 21 CFR Part 11 to ensure that her clients not only meet regulatory requirements but also excel in their product development processes. Her strategic thinking and adeptness at implementing quality management systems enable her to provide comprehensive support, from drafting compelling grant applications to developing investor decks that effectively communicate the value of innovative projects.
As a member of site leadership, Mary is currently supporting multiple programs, where her skills in validation and verification (V&V), change control, and Corrective and Preventive Action (CAPA) are instrumental in fostering a culture of compliance and excellence. With her extensive background and a keen eye for detail, Mary Smith is a vital asset for organizations looking to navigate the regulatory landscape and achieve their clinical and commercial objectives.
Quality, Regulatory and Clinical Consulting at Freelance in January 2024 to Present
Vice President Regulatory Affairs, Quality Assurance and Clinical at Chronus Health in April 2022 to October 2023
Vice President, Regulatory Affairs and Quality at Freenome in February 2020 to March 2022
Senior Director, Safety, Quality Assurance and Regulatory Affairs at Advanced Cell Diagnostics - a Bio-Techne Company in June 2018 to January 2020
Director Regulatory Policy, Digital Medicines and Medical Devices at Novartis in January 2009 to June 2018
Board Member at IPAC RS in January 2007 to January 2015
Associate Director Regulatory Affairs at Nektar Therapeutics (formerly Inhale Therapeutic Systems Inc.) in June 2005 to December 2008
Director Quality Assurance & Regulatory Affairs at Hitachi Chemical Diagnostics in January 2000 to January 2005
Director Buisness Development at Brand Institute in January 1999 to January 2000
Market Analyst - Oncology at Stanford Research Institute in January 1998 to January 1999
Various Quality & Compliance at Abbott Laboratories in January 1992 to January 1998
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Start-up Consulting
Regulatory
Medical device
Technical Documentation
Strategic Thinking
Regulatory Strategy
Combination Products
Medical Devices
Quality System
Auditing
Due Diligence
Regulatory Submissions
IND
Clinical Trials
Biotechnology
Pharmaceutics
Biologics
Biopharmaceuticals
Regulatory Requirements
GxP
Clinical Development
IVD
Drug Development
Strategy
FDA
Regulatory Affairs
Validation
V&V
Technology Transfer
Pharmaceutical Industry
ISO 13485
GLP
CRO
CAPA
GMP
Oncology
GCP
Quality Assurance
Lifesciences
Sop
Quality Auditing
CMC
21 CFR Part 11
Change Control
Drug Delivery
eCTD
Drug Discovery
Corrective and Preventive Action (CAPA)
SOP
U.S. Food and Drug Administration (FDA)
U.S. Title 21 CFR Part 11 Regulation
Verification and Validation (V&V)
Life Sciences
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Discover more about FreelanceWhat is Mary Smith email address?
Email Mary Smith at [email protected]. This email is the most updated Mary Smith email found in 2026.
How to contact Mary Smith?
To contact Mary Smith send an email to [email protected]. (updated on October 29, 2024)
What company does Mary Smith work for?
Mary Smith works for Freelance
What is Mary Smith's role at Freelance?
Mary Smith is Quality, Regulatory and Clinical Consulting
What is Mary Smith's Phone Number?
Mary Smith's phone (**) *** *** 636
What industry does Mary Smith work in?
Mary Smith works in the Medical Equipment Manufacturing industry.
Mary Smith Email Addresses
Mary Smith Phone Numbers
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