2023 -now Principal Consultant, Quality and Regulatory Affairs @
2022 -2023 Management Consultant @
2009 -2013 Vice President, Regulatory Affairs @
2023 -now President @ MKM MEDDEV Strategies LLC
2013 -2015 Sr. Director, Regulatory Affairs and Quality Assurance @
2008 -2009 VP, Regulatory Affairs @
2002 -2007 Vice President, RA and QA @
1996 -2001 Vice President, RA and QA and CA @ NeoPath Medical
Mary Moore Education
University of Washington
M.S.E. (Bioengineering)
1985-1987
Gonzaga University
Bachelor of Science (B.S.) (Human Biology)
1981-1985
Gonzaga University
University of Washington
Mary Moore Skills
Regulatory Requirements
Product Development
Quality Control
Working with Surgeons
Engineering
Business Development
Standard Operating Procedure (SOP)
Problem Solving
Auditing
Regulatory Standards
Supplier Quality Management
Regulatory Compliance
Management
Good Clinical Practice (GCP)
Good Manufacturing Practice (GMP)
Quality Management
Design Control
ISO 13485
FDA
Medical Devices
PMA
V&V
CAPA
Regulatory Affairs
Clinical Research
ISO 14971
Quality System
Biotechnology
Clinical Trials
Cross-functional Team Leadership
Validation
Biomedical Engineering
Regulatory Submissions
R&D
Product Launch
Clinical Development
Commercialization
CE marking
Quality Assurance
Cardiology
Medical Imaging
Lifesciences
U.S. Food and Drug Administration (FDA)
Cross Functional Team
Cross Functional Team Leadership
u.s. Food and Drug Administration Fda
u.s. Food and Drug Administration
Mary Moore Summary
Mary Moore, based in Edmonds, WA, US, is currently a Principal Consultant, Quality and Regulatory Affairs at Oriel STAT A MATRIX. Mary Moore brings experience from previous roles at Verathon, SonoSite, MKM MEDDEV Strategies LLC and FUJIFILM Medical Systems U.S.A., Inc.. Mary Moore holds a 1985 - 1987 M.S.E. in Bioengineering @ University of Washington. With a robust skill set that includes Regulatory Requirements, Product Development, Quality Control, Working with Surgeons, Engineering and more. Mary Moore has 2 emails and 4 mobile phone numbers on RocketReach.
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