| Resume alert | Resumes 31 - 40 of 585 |
Medical Device Tech Transfer
Fremont, CA
... Select contract labs for formal stability program and product release, qualify them for compliance and GMP per FDA and Health Canada requirement. Conduct external GMP audit at contract lab, supplier, and contract manufacture in compliance with FDA, ... - 2023 Nov 17
... Select contract labs for formal stability program and product release, qualify them for compliance and GMP per FDA and Health Canada requirement. Conduct external GMP audit at contract lab, supplier, and contract manufacture in compliance with FDA, ... - 2023 Nov 17
Project Management Facilities
San Francisco, CA
... & EHS Oversee and lead the Facilities/maintenance functions to ensure proper operations and maintenance of all building systems in alignment with quality requirements of FDA for Medical Device Manufacturer Registration, ISO 13485, & MDSAP. ... - 2023 Nov 12
... & EHS Oversee and lead the Facilities/maintenance functions to ensure proper operations and maintenance of all building systems in alignment with quality requirements of FDA for Medical Device Manufacturer Registration, ISO 13485, & MDSAP. ... - 2023 Nov 12
Machine Operator
Alameda, CA
... processes for building medical devices • Constant training to Ensure SOP (Standard operation practices) are up to date within FDA requirements • Ordering of materials needed for assemblies • Processing NCMR requests and scheduling with coordinating ... - 2023 Nov 06
... processes for building medical devices • Constant training to Ensure SOP (Standard operation practices) are up to date within FDA requirements • Ordering of materials needed for assemblies • Processing NCMR requests and scheduling with coordinating ... - 2023 Nov 06
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
Estate/House Manager
Atherton, CA
... Assisted clinical trial physicians prepare clinical evaluation reports, product filings with European Medical Device regulations in addition to FDA officers. Assisted with regulatory affairs development, reports and compliance. Worked closely with ... - 2023 Oct 21
... Assisted clinical trial physicians prepare clinical evaluation reports, product filings with European Medical Device regulations in addition to FDA officers. Assisted with regulatory affairs development, reports and compliance. Worked closely with ... - 2023 Oct 21
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