Mike Goodson

Senior Director, Regulatory Affairs at MCRA, LLC

Role: Senior Director, Regulatory Affairs at MCRA, an IQVIA business
Location: Washington, DC, US
LinkedIn followers: 500 followers

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About Mike Goodson

Seasoned regulatory affairs expert with 15+ years of extensive experience in global…

Experience

Senior Director, Regulatory Affairs
MCRA, an IQVIA business
Sep 2023 — Present · Washington, DC, US

Skills

Cardiology
21 Cfr Part 11
Software Documentation
Regulatory Submissions
Pharmaceutical Industry
Fda
Cross-Functional Team Leadership
Regulatory Affairs
Lifesciences
Capa
Clinical Development
Clinical Trials
Quality Assurance
Regulatory Requirements
Gmp
Biotechnology
Process Improvement
Quality System
Validation

Contact information

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Work email
m•••••••@mcra.com
Personal email
•••••@•••••.com
Direct dial
+15•••••••11

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Current company

MCRA, an IQVIA business

Medical Equipment Manufacturing · 257 employees · Founded 2004 · Washington, District of Columbia, United States

MCRA, an IQVIA business, is a leading full-service medical device, diagnostics, and biologics CRO and consulting advisory firm helping global healthcare companies maximize the value of their innovations. Using an integrated approach informed by the entirety of the commercialization process, we propel healthcare innovations in all stages of development through the product pathway. MCRA offers Regulatory, Clinical Research, Reimbursement, Healthcare Compliance, Quality Assurance, Due Diligence, AI & Imaging, Digital Health, Talent Solutions, and Cybersecurity services. Our exceptional team includes 25+ former FDA officials, payer medical directors, industry veterans, and partners from the world’s most respected medical institutions. We have extensive expertise in the therapeutic areas of orthopedics, spine, biologics, cardiovascular, diagnostic imaging, wound care, artificial intelligence, dental, anesthesia, general surgery, digital health, neurology, robotics, oncology, general and plastic surgery, urology, in vitro diagnostic (IVD) devices, regenerative medicine and more. At MCRA, we work at the speed of science, and our world-class expertise unlocks multiple barriers to success. To learn more, visit mcra.com.

mcra.com

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