Karen E Matis
age ~63
from Westerville, OH
- Also known as:
-
- Karen N Matis
- Karen E Nygren
- Karen E Matin
- Phone and address:
-
5094 Saint Andrews Dr, Westerville, OH 43082
(614)7949244
Karen Matis Phones & Addresses
- 5094 Saint Andrews Dr, Westerville, OH 43082 • (614)7949244
- Columbus, OH
- Taunton, MA
- Pickerington, OH
- Quincy, MA
- 5094 Saint Andrews Dr, Westerville, OH 43082
Work
-
Company:Enlumin regulatory consultingNov 2019
-
Position:President, enlumin regulatory consulting
Education
-
School / High School:Boston University1987 to 1988
-
Specialities:Business Administration, Business
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
Ranks
-
Certificate:• Regulatory Affairs Certification (Rac) By Examination, 2009, Regulatory Affairs Professional Society (Raps)
Industries
Medical Devices
Resumes
President, Enlumin Regulatory Consulting
view sourceLocation:
Columbus, OH
Industry:
Medical Devices
Work:
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
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
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
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)
• Certified Clinical Research Associate (Ccra), By Examination, 2009, Association of Clinical Research Professionals (Acrp)
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)
Vehicle Records
-
Karen Matis
view source -
Address:5094 Saint Andrews Dr, Westerville, OH 43082
-
VIN:1HGCM66587A072805
-
Make:HONDA
-
Model:ACCORD
-
Year:2007
Karen Nygren Matis
view sourceFriends:
Kristin Bonar, Michael Vawter, Erin Scott, Paul Louden, LuAnn Antonazzo Davanzo
Karen Matis
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Classmates
Karen Matis New hyde par...
view sourceKaren 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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Karen Matis
Youtube
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