Elizabeth Malo
- Role
- Principal Regulatory Consultant at Medreg Consulting, Llc
- Location
- Denver, CO, US
- LinkedIn followers
- 500 followers
Experience
Principal Regulatory Consultant
May 2017 — Present
Education
Stony Brook University
Marine Biology
1992 — 1994
University of Phoenix
BS, Business Management, Marketing
2007 — 2009
Northeastern University
MS, Regulatory Affairs for Drugs, Biologics, and Medical Devices
2010 — 2013
Skills
- Quality Control
- 21 Cfr Part 11
- Ce Marking
- Strategy
- Corrective and Preventive Action (Capa)
- Regulatory Submissions
- Medical Devices
- Lifesciences
- Pdp Process
- Product Launch
- Regulatory Requirements
- Gmp
- R&D
- Technology Transfer
- Sop
- Oncology
- Quality Assurance
- Microsoft Office
- Product Development
- Biotechnology
- Regulatory Affairs
- Pharmaceutical Industry
- Agile Methodologies
- Iso 14971
- Capa
- Agile
- Risk Management
- Process Improvement
- Iso 13485
- Validation
- Software Documentation
- Project Management
- Leadership
- Laboratory
- V&V
- Cross-Functional Team Leadership
- Pma
- U.s. Food and Drug Administration (Fda)
- Management
- Clinical Trials
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