Elizabeth Malo
Principal Regulatory Affairs Consultant
M.S. Regulatory Affairs (Drugs, Biologics & Medical Devices) – Northeastern University, Massachusetts
B.S. Business Management, Marketing – University of Phoenix, Arizona
Regulatory Affairs professional with over 20 years of experience working with government and industry. Significant experience in product development, analysis and reporting of medical product technical data and applications for use in human healthcare planning and management. After significant experience in Quality Assurance, Marketing, Product Development, and Project Management activities, I have focused on Regulatory Affairs activities obtaining global registrations for over 200 medical devices, becoming familiar with international registration requirements. Working in industry, I have developed positive and effective relationships with public health authorities at local, state, and federal levels to establish innovative policy and safe practices for health services and products.
As team leader and director of regulatory affairs in both well-established corporations (Roche/Ventana Medical Systems, Covidien/Medtronic) and successful entrepreneurial organizations (Biodesix, InDevR), I have leveraged my experience to help direct and build successful teams focused on achieving strategic goals and objectives.
Key objectives: engage leadership with several strategic options paired with clear definition of risks and benefits for each to promote best decision making, foster teamwork and sense of urgency and agility to adapt to unforeseen circumstances and stay focused on goals and objectives.
Responsibilities as principal consultant: manage client contracts, consult with staff, deliver regulatory strategies, and manage submissions.
Scope of engagement: small to medium-sized enterprises and well-established international medical products companies.
B.S. Business Management, Marketing – University of Phoenix, Arizona
Regulatory Affairs professional with over 20 years of experience working with government and industry. Significant experience in product development, analysis and reporting of medical product technical data and applications for use in human healthcare planning and management. After significant experience in Quality Assurance, Marketing, Product Development, and Project Management activities, I have focused on Regulatory Affairs activities obtaining global registrations for over 200 medical devices, becoming familiar with international registration requirements. Working in industry, I have developed positive and effective relationships with public health authorities at local, state, and federal levels to establish innovative policy and safe practices for health services and products.
As team leader and director of regulatory affairs in both well-established corporations (Roche/Ventana Medical Systems, Covidien/Medtronic) and successful entrepreneurial organizations (Biodesix, InDevR), I have leveraged my experience to help direct and build successful teams focused on achieving strategic goals and objectives.
Key objectives: engage leadership with several strategic options paired with clear definition of risks and benefits for each to promote best decision making, foster teamwork and sense of urgency and agility to adapt to unforeseen circumstances and stay focused on goals and objectives.
Responsibilities as principal consultant: manage client contracts, consult with staff, deliver regulatory strategies, and manage submissions.
Scope of engagement: small to medium-sized enterprises and well-established international medical products companies.