Kurt Norton Email and Phone Number
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Kurt Norton is a Regulatory Affairs Senior Associate at Conventus Biomedical Solutions. He is an accomplished Scientist and Regulatory Affairs Professional. Kurt has held multiple Scientist positions in biotechnological companies developing and manufacturing in vitro diagnostic assays, medical devices and biologics. Kurt has regulatory affairs experience with product candidates in development and commercial products. He has hosted an on-site FDA BIMO inspection and is familiar with US, HC, EU and ICH regulations. Experience with IND, NDA, DMF and De Novo submissions. Kurt has prepared summary reports, addressed information requests, created SOPs and amended product inserts. Prior to his regulatory affairs career, Kurt has extensive experience as a Scientist in research organizations utilizing monoclonal antibody or nucleic acid technology to detect cancer cells, viruses, bacteria and other molecules of interest in the human body. He has served as a peer trainer and travelled to provide training to personnel performing clinical trials.
Conventus Biomedical Solutions, Inc.
View- Website:
- conventusbiomed.com
- Employees:
- 6
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Conventus Biomedical Solutions, Inc.La Mesa, Ca, Us
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Regulatory Affairs Senior AssociateConventus Biomedical Solutions, Inc. Feb 2019 - PresentSan Diego, California, Us• Formatted and published regulatory documents, using applicable software tools• Created and maintained templates for regulatory documents and submissions• Reviewed, proofread, edited documents for all modules of electronic regulatory submissions• Hosted weekly international teleconference with clients for submission planning
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Regulatory AssociateConventus Biomedical Solutions, Inc. Jun 2018 - Feb 2019San Diego, California, UsRegulatory Associate, Regulatory Affairs • Regulatory strategy and submissions• Hosted on-site BIMO inspection• Compilation and publishing of submissions to various health authorities• IND, NDA, DMF• Regions: US, Canada
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Regulatory Affairs SpecialistSekisui Diagnostics Jun 2021 - Mar 2022Burlington, Ma, UsPrepared letters of authority for customs clearance to collect international reagent shipments. Prepared RA & QA SOP document revisions in CATSWeb (Corrective Action Tracking System).Added & removed holds on products for sale in numerous EU and other countries worldwide. -
Regulatory Affairs SpecialistHologic, Inc. Mar 2016 - Sep 2016Marlborough, Ma, Us• Annual reports, FDA• Amended Product Insert• Supported labeling section of PMA submission• Product name change, Health Canada• Information requests, Health Canada• Prepared section summary reports in preparation to complete an Application for a New Medical Device, Health Canada -
Senior Associate Research OperationsAmgen Dec 2015 - Mar 2016Thousand Oaks, Ca, Us• Pre-pivotal Drug Substance Technologies, Viscosity• Reviewed and approved R&D documentation• Data verification• Organized and cleaned laboratory to prepare for new instrumentation• Lab management, vendor collaboration, employee training -
ScientistHologic (Formerly Gen-Probe) Jan 2008 - Oct 2012Ca, 92121, Us• End-point PCR, real-time PCR, quantitative PCR• Nucleic acid amplification, primer design• Stability testing, spike and recovery, interfering substances• Developed and transferred Methicillin-resistant Staphylococcus aureus (MRSA) assay to collaborating company that met contract specifications • Completed project ahead of deadline and co-authored report that triggered a $3 million bonus to Gen-Probe• Scientific Writing, Standard Operating Procedures, Qualification Reports -
Associate ScientistHologic (Formerly Gen-Probe) Jun 1999 - Jan 2008Ca, 92121, Us• End-point PCR, real-time PCR, quantitative PCR • Nucleic acid amplification, primer design• Product scale-up in MNF• Product transfer from R&D to MNF• Design of Experiments (DOE)
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ConsultantLpath Therapeutics Inc. Jan 2006 - Nov 2006• Research Consultant• Enzyme-Linked Immunosorbent Assay (ELISA)• Document Writing -
Associate ScientistBeckman Coulter (Hybritech, Incorporated) Nov 1988 - Jun 1999Brea, California, Us• Monoclonal antibodies, protein assays, protein purification, cell culture• Product scale-up in MNF• Product transfer from R&D to MNF• Chemiluminescent assay development• Colloidal Gold coating• Clinical site operator training• Contributed to 510(K) submission documents -
Senior Research AssociateHybritech Incorporated Jul 1986 - Nov 1988• Monoclonal antibodies, protein assays, protein purification, cell culture• FDA and CBER regulated R&D and cGMP manufacturing environments• Experimental design• Assay reagent formulation• Immunoassay development, ELISA, Western Blot
Kurt Norton Skills
Kurt Norton Education Details
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Uc San DiegoRegulatory Affairs For The Biomedical Industry Professional Certificate Program. -
San Diego State UniversityChemistry
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University Of IowaBiochemistry
Frequently Asked Questions about Kurt Norton
What company does Kurt Norton work for?
Kurt Norton works for Conventus Biomedical Solutions, Inc.
What is Kurt Norton's role at the current company?
Kurt Norton's current role is Regulatory Affairs Senior Associate at Conventus Biomedical Solutions, Inc..
What is Kurt Norton's email address?
Kurt Norton's email address is kn****@****med.com
What is Kurt Norton's direct phone number?
Kurt Norton's direct phone number is +161946*****
What schools did Kurt Norton attend?
Kurt Norton attended Uc San Diego, San Diego State University, University Of Iowa.
What are some of Kurt Norton's interests?
Kurt Norton has interest in Football, Collecting Antiques, Exercise, Sweepstakes, Nascar, Home Improvement, Reading, Sports, Watching Auto Racing, Watching Basketball.
What skills is Kurt Norton known for?
Kurt Norton has skills like Biotechnology, Molecular Biology, Biochemistry, Protein Chemistry, Life Sciences, Dna, Elisa, Protein Purification, Pcr, Qpcr, Genomics, Cell Culture.
Who are Kurt Norton's colleagues?
Kurt Norton's colleagues are Steven Kradjian.
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