Enlumin Regulatory Consulting
President, Enlumin Regulatory Consulting
Flowonix Medical Nov 2016 - Nov 2019
Senior Vice President, Clinical, Quality and Regulatory Affairs
Enlumin Regulatory Consulting Nov 2016 - Nov 2019
President
Cardiox Corporation Jan 2013 - Jan 2016
Vice President, Quality and Regulatory Affairs
Cardiox Corporation Jun 2010 - Jan 2013
Senior Director, Quality and Regulatory Affairs
Education:
Boston University 1987 - 1988
Gustavus Adolphus College 1979 - 1983
Bachelors, Biology
Institute of European Studies, Vienna Austria 1981 - 1982
Skills:
Regulatory Affairs Medical Devices Fda Quality System Iso 13485 Pharmaceutical Industry Gmp Cross Functional Team Leadership Regulatory Requirements Design Control Quality Management Process Improvement Clinical Development Strategy Project Management Quality Auditing Quality Assurance Product Development Clinical Trials U.s. Food and Drug Administration Gcp Capa Quality Control Iso Operational Excellence Healthcare Hardware Diagnostics Lifesciences Process Simulation Change Control Continuous Improvement Computer System Validation Validation V&V Manufacturing Clinical Research Regulatory Submissions Biopharmaceuticals Cardiology Pharmaceutics Technology Transfer Regulations Business Process Improvement R&D Iso 14971 Analysis Drug Development 21 Cfr Part 11 Gxp Life Sciences
Certifications:
• Regulatory Affairs Certification (Rac) By Examination, 2009, Regulatory Affairs Professional Society (Raps) • Certified Clinical Research Associate (Ccra), By Examination, 2009, Association of Clinical Research Professionals (Acrp) Linkedin Project Management Simplified • Regulatory Affairs Certification (Rac) By Examination, 2009, Regulatory Affairs Professional Society (Raps) • Certified Clinical Research Associate (Ccra), By Examination, 2009, Association of Clinical Research Professionals (Acrp)
Karen Matis 1964 graduate of Herricks High School in New hyde park, NY is on Classmates.com. See pictures, plan your class reunion and get caught up with Karen and other high ...
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