Richard Stewart Email & Phone Number | □ Serves as Chief Regulatory Affairs & Quality Officer for Digital Health, Precision Health, SaMD, medical devices, & CDx. □ +10 years Quality Systems & Regulatory Affairs Senior Executive Leadership experience and +25 years Life Sciences professional. □ Solutions-driven leader partnering quality management systems, cGMP, GCP, GLP, and CRO services supporting global regulatory strategies, business development, clinical affairs, sales & marketing, product development life cycle, risk management, operations, manufacturing, supply chain, post-market reporting, domestic regulatory submissions and international product registrations. □ Certified training and direct work experience in the following: FDA 21 CFR Parts 11, 50, 54, 56, 800, 820 to 1299 • ISO 13485 MDR/MDSAP/CMDCAS • ISO 14971 • ICH E6 GCP • HHS Title 45 CFR 46 • ISO 14155 • IEC 82304 • IEC 62304 • Canadian CMDR SOR/98-282 • BS EN 980:2008 CE Req. • 93/42/EEC- MDD to MDR 2017/745 • 98/79/EC IVDD • IRB, Investigators, & Sponsors • FDA & Notified Body Audits • Risk Management • Design & Process Controls: SAMD, AI/ML-enabled Medical Devices, IVDD & Clinical • CDRH and CBER Procedures • Lead Auditor Internal & Supplier Audit Inspections • RUO/IUO • International Registrations & Rqmts.• Facility/Equipment Qualification • Design Transfer • Process Validation • Software Validation • Software as a Medical Device • Test Method Development • LDT CLIA/CAP □ Builds and Oversees global & FDA regulatory affairs teams and submissions: International Regulatory Registrations for +15 countries, FDA EUA, IDE, Pre-Sub, De Novo, Traditional 510(k), PMA, CDx, Technical Dossier, CE Marking and Product Registrations, CLIA Waiver/Amendments, Certificate to Foreign Government, and Note/Add-to-Files. □ Consults and responsible for building leadership teams to meet regulatory and quality cGxP/QMS functions.

Richard Stewart

□ Serves as Chief Regulatory Affairs & Quality Officer for Digital Health, Precision Health, SaMD, m...
San Francisco, California, United States

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Richard Stewart’s Email richardstewart@verily.com

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Richard Stewart’s Location San Francisco, California, United States

Richard Stewart’s Current Industry Artrya

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Work Experience

Artrya

Chief Regulatory Affairs & Quality Officer

2023-02-01 00:00:00 - Present

Verily Life Sciences

Head of Regulatory Affairs & Interim Head of Quality

2019-02-01 00:00:00 - 2023-01-01 00:00:00

Nanostring Technologies

Vice President of Regulatory Affairs & Quality Assurance

2018-01-01 00:00:00 - 2019-02-01 00:00:00

Tosoh Bioscience

Vice President of Quality Assurance & Regulatory Affairs

2017-01-01 00:00:00 - 2018-01-01 00:00:00

Dxterity

Director of Quality Assurance & Regulatory Affairs

2014-12-01 00:00:00 - 2017-01-01 00:00:00

Teco Diagnostics

Director of Quality Systems & Regulatory Affairs

2012-09-01 00:00:00 - 2014-12-01 00:00:00

Eos Neuroscience Inc At The Keck School Of Medicine Usc

Quality Research Scientist / Regulatory Affairs Operations Specialist

2010-07-01 00:00:00 - 2012-07-01 00:00:00

Csu San Marcos

OBRT Seminar Lecturer

2011-03-01 00:00:00 - 2011-03-01 00:00:00

City Of Hope Irell And Manella Graduate School Of Biological Sciences

PhD Biological Sciences: Molecular & Stem Cell Biology - June 2010

2004-01-01 00:00:00 - 2010-01-01 00:00:00

Csu Fullerton

Part-time Faculty Department of Biology

2008-01-01 00:00:00 - 2008-05-01 00:00:00

Gladstone Institutes

Research Associate III

2000-01-01 00:00:00 - 2004-01-01 00:00:00

Skills

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Languages

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FAQ About Richard Stewart

Richard Stewart is located at
San Francisco, California, United States

Richard Stewart is a □ Serves as Chief Regulatory Affairs & Quality Officer for Digital Health, Precision Health, SaMD, medical devices, & CDx. □ +10 years Quality Systems & Regulatory Affairs Senior Executive Leadership experience and +25 years Life Sciences professional. □ Solutions-driven leader partnering quality management systems, cGMP, GCP, GLP, and CRO services supporting global regulatory strategies, business development, clinical affairs, sales & marketing, product development life cycle, risk management, operations, manufacturing, supply chain, post-market reporting, domestic regulatory submissions and international product registrations. □ Certified training and direct work experience in the following: FDA 21 CFR Parts 11, 50, 54, 56, 800, 820 to 1299 • ISO 13485 MDR/MDSAP/CMDCAS • ISO 14971 • ICH E6 GCP • HHS Title 45 CFR 46 • ISO 14155 • IEC 82304 • IEC 62304 • Canadian CMDR SOR/98-282 • BS EN 980:2008 CE Req. • 93/42/EEC- MDD to MDR 2017/745 • 98/79/EC IVDD • IRB, Investigators, & Sponsors • FDA & Notified Body Audits • Risk Management • Design & Process Controls: SAMD, AI/ML-enabled Medical Devices, IVDD & Clinical • CDRH and CBER Procedures • Lead Auditor Internal & Supplier Audit Inspections • RUO/IUO • International Registrations & Rqmts.• Facility/Equipment Qualification • Design Transfer • Process Validation • Software Validation • Software as a Medical Device • Test Method Development • LDT CLIA/CAP □ Builds and Oversees global & FDA regulatory affairs teams and submissions: International Regulatory Registrations for +15 countries, FDA EUA, IDE, Pre-Sub, De Novo, Traditional 510(k), PMA, CDx, Technical Dossier, CE Marking and Product Registrations, CLIA Waiver/Amendments, Certificate to Foreign Government, and Note/Add-to-Files. □ Consults and responsible for building leadership teams to meet regulatory and quality cGxP/QMS functions.

Richard Stewart currently works in the Artrya |

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Richard Stewart has prior
experience in the following industries:
Verily Life Sciences | Nanostring Technologies | Tosoh Bioscience | Dxterity | Teco Diagnostics | Eos Neuroscience Inc At The Keck School Of Medicine Usc | Csu San Marcos | City Of Hope Irell And Manella Graduate School Of Biological Sciences | Csu Fullerton | Gladstone Institutes

Richard Stewart has the following professional experience:
Artrya | Verily Life Sciences | Nanostring Technologies | Tosoh Bioscience | Dxterity | Teco Diagnostics | Eos Neuroscience Inc At The Keck School Of Medicine Usc | Csu San Marcos | City Of Hope Irell And Manella Graduate School Of Biological Sciences | Csu Fullerton | Gladstone Institutes