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San Rafael, CA
... I have a proven track record with FDA and International Regulatory agencies and excellent knowledge of FDA, ICH, GCP Guidelines; Expert at clinical research design and methodology --- Blue Water Counseling Port Huron, MI 48060, 5/2023 -current ...
- 2023 Dec 22
San Francisco, CA
... independently ● Lead code reviews in SQL, Javascript, and Python ● Creation of validation protocols and managing test matrix ● FDA 21 CFR 11 for devices and electronic records ● Lead offshore and onshore remote teams PROFESSIONAL EXPERIENCE: Diamond ...
- 2023 Dec 12
San Francisco, CA
... Cercacor Laboratories, Irvine, CA (Remote) April 2021 - July 2021 Senior Product UX/UI/Visual Design Technology Lead - Product Design - FDA Medical Health, Fitness, and Wellness Mobile Apps ● Lead a small team of 2 designers and 2 researchers on ...
- 2023 Dec 03
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
Vallejo, CA
... •Extensive experience in the management and assessment of adverse events and serious adverse events as per FDA, EU, and CE guidelines •In-Vitro Diagnostics Research and Development for 8 years •Clinical trials in Neurosurgery, Neurology, and ...
- 2023 Nov 04
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
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
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
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
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