Odero G.
Director of Regulatory Affairs (Global Markets) @Insulet Corporation
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WORK HISTORY
Director of Regulatory Affairs (Global Markets) @Insulet Corporation
Acton, MA, US
Responsible for working with local and global cross functional partners and Regulators to build and execute robust plans that grow the existing business and launch new and innovative products in new global regions
EDUCATION
SAI Global
Lean Six Sigma Green Belt Course
Regulatory Affairs Professional Society
Regulatory Affairs Certification (RAC), RAC (Global):
Northwestern University - Kellogg School of Management
Regulatory Affairs Professionals Society Executive Development Program., Organizational Leadership
University of Technology, Sydney
Master's degree, M.I.P, Intellectual (Industrial) Property Law (Patent, TradeMark & Design Law)
RAPS ONLINE UNIVERSITY
Regulatory Affairs Certificate, Medical Devices
ABOUT ODERO G.
Results-oriented, RAC (Global) credentialed, Regulatory, Quality, Systems & Standards, and Clinical professional, strong on strategic leadership and development with solid scientific, technical, and IP background in medical technology. Over 20 years hands-on experience spanning governmental, private healthcare, and biotechnology industries. • Core leadership competencies include; strategic development, communication, organisational change agent, analytical problem-solving skills, negotiation skills and cross-functional team-based collaboration approaches. • Proven ability to analyze global Regulatory and Quality trends, products & services; and design, develop and implement solutions that improve compliance, product Quality, and competitive performance whilst aligning with corporate objectives and maintaining budgetary commitments. • Demonstrated successful management of: International Regulatory Affairs/Regulatory Intelligence (RI), Quality, Clinical Affairs, Market Access and Reimbursement of medical devices (Class I, IIa/b, AIMD), IVD, Biologics, and combination products. • Proven ability to manage people and delivery of requirements, set priorities, manage progress, and improve or introduce new methods and processes using Lean Six Sigma skills (DMAIC model) and Agile SaFE.
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