| Resume alert | Resumes 41 - 50 of 148 |
Sponsor Project Manager
San Francisco, CA
... Clinical Trials Associate ● Obtains, reviews, processes, and tracks study related documents (CVs, FDA 1572s, lab certifications, IRB approvals, contracts, protocols, etc.). ● Sets-up and maintains the Trial Master File (TMF) using Veeva system. ● ... - 2021 Jul 28
... Clinical Trials Associate ● Obtains, reviews, processes, and tracks study related documents (CVs, FDA 1572s, lab certifications, IRB approvals, contracts, protocols, etc.). ● Sets-up and maintains the Trial Master File (TMF) using Veeva system. ● ... - 2021 Jul 28
Research Fellow Scientist
Novato, CA
... Nov 2017-present • Manage regulatory operations for SaMD for vendors and FDA and validate the scope for deliverables acceptance, by working continuously with quality and regulatory team in order to utilize EHR from hospitals or organizations such as ... - 2021 Jun 19
... Nov 2017-present • Manage regulatory operations for SaMD for vendors and FDA and validate the scope for deliverables acceptance, by working continuously with quality and regulatory team in order to utilize EHR from hospitals or organizations such as ... - 2021 Jun 19
Medical Physician
Ross, CA, 94957
... Raised $3.8M FDA cleared, Class 2 device Directed five clinical trials for safety and efficacy 11 United States Patents issued ‘Clearinse’ nasal wash system on market. ‘ClearLab’ home flu testing development underway. 2016-present Aphelion Capital. ... - 2021 Jan 03
... Raised $3.8M FDA cleared, Class 2 device Directed five clinical trials for safety and efficacy 11 United States Patents issued ‘Clearinse’ nasal wash system on market. ‘ClearLab’ home flu testing development underway. 2016-present Aphelion Capital. ... - 2021 Jan 03
SQA Analyst
San Francisco, CA
... Dublin, CA February 2020-September 2020 Software Quality Assurance Analyst • Executed manual software test procedures on proprietary, FDA regulated medical devices, in compliance with ISO 14971, ISO 13485 (functional and non-functional testing, e.g. ... - 2020 Dec 08
... Dublin, CA February 2020-September 2020 Software Quality Assurance Analyst • Executed manual software test procedures on proprietary, FDA regulated medical devices, in compliance with ISO 14971, ISO 13485 (functional and non-functional testing, e.g. ... - 2020 Dec 08
Sap Manager
San Francisco, CA
... Experience in FMCG, Pharma (best practices, FDA-21 CFR Part11), Retail and process industries. Effective communicator with excellent relationship management skills, Has the ability to relate to people at any level of business and management. 12+ ... - 2020 Sep 17
... Experience in FMCG, Pharma (best practices, FDA-21 CFR Part11), Retail and process industries. Effective communicator with excellent relationship management skills, Has the ability to relate to people at any level of business and management. 12+ ... - 2020 Sep 17
Mechanical Engineer
Vallejo, CA
... as communications lead with a team of colleagues, faculty, and sponsors to create the electro- mechanical machine that uses FDA-approved components • Utilized sub-assemblies in SolidWorks to stage major processes of root-grating automation • ... - 2020 Sep 10
... as communications lead with a team of colleagues, faculty, and sponsors to create the electro- mechanical machine that uses FDA-approved components • Utilized sub-assemblies in SolidWorks to stage major processes of root-grating automation • ... - 2020 Sep 10
Business Analyst consulting marketing regulatory affairs PMP
San Francisco, CA
... • Successfully obtained Special Import Licensing from Taiwan FDA for melanoma drug, ZELBORAF. • Responsible for developing strong partnerships with KOLs through scientific resource and academic supports. MA in Market Access and Corporate Affairs – ... - 2020 Sep 09
... • Successfully obtained Special Import Licensing from Taiwan FDA for melanoma drug, ZELBORAF. • Responsible for developing strong partnerships with KOLs through scientific resource and academic supports. MA in Market Access and Corporate Affairs – ... - 2020 Sep 09
Quality Assurance Training
Richmond, CA
... Extensive experience (active participation) with various regulatory inspections of QC and QA such as FDA, ISO, EMEA, Mexico. Certified ISO Lead Auditor. Expert in EtQ, SAP, TrackWise, SCORE, TOPAS, LMS, and LIMS. PROFESSIONAL EXPERIENCE Lonza - ... - 2020 Apr 10
... Extensive experience (active participation) with various regulatory inspections of QC and QA such as FDA, ISO, EMEA, Mexico. Certified ISO Lead Auditor. Expert in EtQ, SAP, TrackWise, SCORE, TOPAS, LMS, and LIMS. PROFESSIONAL EXPERIENCE Lonza - ... - 2020 Apr 10
Engineer Software
Novato, CA
... Full SDLC Project Experience in Agile, Waterfall, and Spiral Models HipTest, Robot Framework, SilkTest, Ranorex and PowerShell Test Plans, Metrics and Test Cases Testing in FDA and ISO Environment Defect Diagnostic and Tracking L10n and I18n Testing ... - 2020 Apr 08
... Full SDLC Project Experience in Agile, Waterfall, and Spiral Models HipTest, Robot Framework, SilkTest, Ranorex and PowerShell Test Plans, Metrics and Test Cases Testing in FDA and ISO Environment Defect Diagnostic and Tracking L10n and I18n Testing ... - 2020 Apr 08
Manager Project
Santa Rosa, CA
... Worked with Steering Committee to complete the final scope for a global template and multiple country roll-outs of Japan, Canada, Germany, Italy, US, UK, France, Netherlands, Australia on a single global instance in an FDA Compliance / CFR Part 11 ... - 2020 Apr 05
... Worked with Steering Committee to complete the final scope for a global template and multiple country roll-outs of Japan, Canada, Germany, Italy, US, UK, France, Netherlands, Australia on a single global instance in an FDA Compliance / CFR Part 11 ... - 2020 Apr 05