- Abbott (Sylmar, CA)
- …Interoperability and Connectivity solutions providing efficient means to improving clinical workflow and outcomes for patients, providers and customers. This ... with appropriate cross-functional teams and internal and external resources ( regulatory , quality, IT, customers, etc.) to ensure Connectivity platform development… more
- Abbott (Alameda, CA)
- …manage the digital health analytics + Work cross functionally with market access, regulatory affairs, medical and clinical resources to deliver on critical ... countries. **About Abbott** Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future,… more
- Cedars-Sinai (Beverly Hills, CA)
- …imaging. This position will provide an excellent opportunity to enable clinical research projects and to foster collaboration with multiple research laboratories. ... to field development through effective project management and compliance with regulatory and safety standards. **Primary Duties and Responsibilities:** + Supervises… more
- ThermoFisher Scientific (San Francisco, CA)
- …with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest ... offers customers process and analytical development capabilities, as well as clinical and commercial manufacturing services, for novel therapies derived from either… more
- Insight Global (San Diego, CA)
- …ServiceNow, NetSuite) o Familiarity of Veeva and it's support functions including: clinical , quality, safety& regulatory * Experience with ERP * Experience ... Job Description A Life Science company based in San Diego, CA is...Database Programming. * Experience supporting validated systems/validation applications for regulatory purposes in a biotech/pharmaceutical company. * Strong understanding… more
- Ascendis Pharma (Palo Alto, CA)
- …Ascendis Pharmacovigilance System Master File (PSMF) + Work collaboratively with ICSR Management, Clinical Trial, QPPV office and Medical Safety Science team for ... Disease and Oncology. Here at Ascendis, we pride ourselves on exceptional science , visionary leadership, and skilled and passionate colleagues. Guided by our core… more
- Abbott (Sylmar, CA)
- …record of FDA-cleared AI tools and SaMD development. + Strong understanding of regulatory pathways and clinical validation. + Demonstrated success in building ... strategies for new FDA 510(k) AI-based SaMD modules. Support international regulatory submissions. + Ensure AI solutions comply with relevant regulatory… more
- Medtronic (Los Angeles, CA)
- …Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies Review and analyze clinical databases for the extraction of ... and with external collaborators to develop programs and processes to meet regulatory reporting requirements Lead or leverage cross functional teams to evaluate,… more
- Abbott (Pleasanton, CA)
- …Institute efficient communication and cross-functional collaborations with marketing, quality, regulatory , clinical , project management, etc, at multiple levels. ... + Interfaces with appropriate internal and external stakeholders ( regulatory , customers, etc.) to ensure development programs meet regulatory and customer… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …brand objectives. Work with other relevant internal stakeholders (eg, Brand Teams, Regulatory Affairs, Market Access, Legal, Clinical ) to help anticipate, ... are provisioned for in a multitude of public policy, legislative, and regulatory regimes and initiatives. Key Responsibilities Serve as the strategic leader of… more