Colleen Murphy
Director of Regulatory and Clinical Affairs at Kaleidoscope Innovation
- Role
- Director of Regulatory and Clinical Affairs at Kaleidoscope Innovation
- Location
- Cincinnati, OH, US
- LinkedIn followers
- 500 followers
About Colleen Murphy
Regulatory Affairs professional with over 20 years of experience, specializing in medical devices.*Broad knowledge of FDA regulations, Health Canada regulations and ICH guidelines.*Areas of Expertise:• Clinical trials protocol development• Clinical trials project operationalization• Clinical trials monitoring• IRB submissions• IDE/IND submissions• Q submission meeting requests• Regulatory assessments • Quality Systems compliance• Marketing and labeling compliance• Standard Operating Procedures development • FDA Part 806 and Health Canada recall coordination• FDA establishment registrations• Health Canada license submissions and renewals • EU Clinical Evaluation Reports
Experience
Director of Regulatory and Clinical Affairs
Jun 2022 — Present · Cincinnati, OH, US
Education
University of Cincinnati
Bachelor of Science, Biology; Microbiology; Microbiology, Biochemistry and Immunology
1994
Northern Kentucky University
Master of Arts, Teaching; Secondary Biology
2006
University of Wisconsin-Madison
Currently enrolled, Clinical and Health Informatics
Skills
- Clinical Trials
- Fda
- Gcp
- Clinical Research
- Regulatory Affairs
- Good Clinical Practice (Gcp)
- Gmp
- Glp
- Data Management
- CRO
- Clinical Development
- Biotechnology
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