| Resume alert | Resumes 31 - 40 of 544 |
Product Development Technical Staff
Redwood City, CA, 94063
... Have had successful CMC submissions and interactions with FDA and EMA. Efforts have resulted in approval of many drug products along with their commercial launches Experience with small as well as large sized molecules from various therapeutic areas ... - 2023 Oct 27
... Have had successful CMC submissions and interactions with FDA and EMA. Efforts have resulted in approval of many drug products along with their commercial launches Experience with small as well as large sized molecules from various therapeutic areas ... - 2023 Oct 27
Transfer Pricing Financial Planning
Kentfield, CA
... Director of Finance, Spire Health, San Francisco 2018 to Jan 2022 • Played key role pivoting Spire from a distressed, wearable technology company to a thriving, FDA-approved medical device entity with 320% year-over-year revenue growth. • Led ... - 2023 Oct 25
... Director of Finance, Spire Health, San Francisco 2018 to Jan 2022 • Played key role pivoting Spire from a distressed, wearable technology company to a thriving, FDA-approved medical device entity with 320% year-over-year revenue growth. • Led ... - 2023 Oct 25
Change Management Patient Safety
Martinez, CA
... Extensive knowledge with QA/QC requirements within FDA regulated medical and pharmaceutical environments (Class I/II), including CE Mark, CMDCAS, MDD and MDR. Leadership capability to accelerate performance of people individually or in a team ... - 2023 Oct 13
... Extensive knowledge with QA/QC requirements within FDA regulated medical and pharmaceutical environments (Class I/II), including CE Mark, CMDCAS, MDD and MDR. Leadership capability to accelerate performance of people individually or in a team ... - 2023 Oct 13
Project Manager Business Intelligence
San Francisco, CA
... Responsible for business requirements processes, development, and deployment, supporting IT solution for Class III Medical Device, and FDA regulation, cGMP, RIM. − Working knowledge of Software development and SQA enterprise B2B, B2C, SaaS, CRM, PLM ... - 2023 Oct 02
... Responsible for business requirements processes, development, and deployment, supporting IT solution for Class III Medical Device, and FDA regulation, cGMP, RIM. − Working knowledge of Software development and SQA enterprise B2B, B2C, SaaS, CRM, PLM ... - 2023 Oct 02
Clinical Research Project Manager
San Francisco, CA
... Proven track record of success in bringing eight drugs to FDA approval for top biotech companies. SKILLS • Project Management • Strategic Tine-line Development • Global Drug Development • Startup Design Specialist • Cross-functional Team Leadership ... - 2023 Sep 30
... Proven track record of success in bringing eight drugs to FDA approval for top biotech companies. SKILLS • Project Management • Strategic Tine-line Development • Global Drug Development • Startup Design Specialist • Cross-functional Team Leadership ... - 2023 Sep 30
Clinical Trial Research
San Francisco, CA
... and training Demonstrates expertise to support SOP development and implementation Demonstrates through knowledge of FDA and EMA Regulations, ICH Guidelines, and GCP governing the conduct of clinical studies Drafts and coordinates review of ... - 2023 Sep 27
... and training Demonstrates expertise to support SOP development and implementation Demonstrates through knowledge of FDA and EMA Regulations, ICH Guidelines, and GCP governing the conduct of clinical studies Drafts and coordinates review of ... - 2023 Sep 27
Senior Project Manager
Oakland, CA
... Core Competencies • Extensive Project Management experience in FDA-regulated industries • US FDA 21 CFR 820 (QSR/cGMP), EU IVDR/MDR, CMDR • ISO-3485, -10993, -14971, IEC60601 • Advanced Technical Writing • Proficient with MS Project, Smartsheet, MS ... - 2023 Sep 25
... Core Competencies • Extensive Project Management experience in FDA-regulated industries • US FDA 21 CFR 820 (QSR/cGMP), EU IVDR/MDR, CMDR • ISO-3485, -10993, -14971, IEC60601 • Advanced Technical Writing • Proficient with MS Project, Smartsheet, MS ... - 2023 Sep 25
Donor Care Quality Assurance
San Francisco, CA
... Across all the locations I've overseen, regulatory bodies such as the FDA, AABB, CSL, Cities, and Counties have consistently acknowledged our compliance and order. My exceptional leadership and communication skills have enabled me to collaborate ... - 2023 Sep 19
... Across all the locations I've overseen, regulatory bodies such as the FDA, AABB, CSL, Cities, and Counties have consistently acknowledged our compliance and order. My exceptional leadership and communication skills have enabled me to collaborate ... - 2023 Sep 19
Document Control Quality Assurance
San Mateo, CA
... GMP, GCP, GMED and FDA experience. ●4+ years of training experience (training new hires) and building curriculums for each department. ●Built, implemented and validated Electronic Document Management Systems for 3 companies. ●20+ years as Subject ... - 2023 Sep 09
... GMP, GCP, GMED and FDA experience. ●4+ years of training experience (training new hires) and building curriculums for each department. ●Built, implemented and validated Electronic Document Management Systems for 3 companies. ●20+ years as Subject ... - 2023 Sep 09
Project Manager Quality Consultant
Pinole, CA
... Responsible for inspection readiness and was the host for five successful audits from June 2009 to Aug 2010 (ISO 13485 -TUV, Internal, state FDA, ISO 13485-LNE/GMED, federal FDA). Culminated in FDA Inspection from 02-03 Aug 10 that resulted in the ... - 2023 Sep 06
... Responsible for inspection readiness and was the host for five successful audits from June 2009 to Aug 2010 (ISO 13485 -TUV, Internal, state FDA, ISO 13485-LNE/GMED, federal FDA). Culminated in FDA Inspection from 02-03 Aug 10 that resulted in the ... - 2023 Sep 06