- J&J Family of Companies (Irvine, CA)
- …ensuring patient safety. Act as medical and/or technical expert in communications with FDA and other Regulatory agencies worldwide. Oversees post market clinical ... and implement clinical research strategies that align with product development and regulatory requirements. + Lead and mentor a team of clinical scientists and… more
- AbbVie (Irvine, CA)
- …requirements. + May coordinate and develop information for reports submitted to the FDA and Global Regulatory Authorities. + May initiate research projects ... and based on strong scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations and emerging issues.… more
- Oracle (Sacramento, CA)
- …of Technical Staff to play a critical technical leadership role to ensure FDA and global regulatory compliance, including secure design, architecture and ... Risk-Based Process and ensure product is maintaining compliance to FDA and other Global regulatory requirements. -...maintaining compliance to FDA and other Global regulatory requirements. - Proficiency in the Java programming language.… more
- Abbott (Sylmar, CA)
- …regulatory requirements. *Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating ... and process development from concept through sustained manufacturing of FDA regulated products. Responsible for production support, maintenance support, performing… more
- Abbott (Sylmar, CA)
- … requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... from varied disciplines including Clinical Medicine, Engineering, Marketing and Regulatory Affairs required. + Strong knowledge of defined development process… more
- Genentech (South San Francisco, CA)
- …environments impacting Roche/Genentech, coupled with thorough knowledge of US regulatory / FDA requirements. + Scientific credibility and enterprise thinking ... as a key medical spokesperson internally and externally with various committees, regulatory bodies, and industry forums. This individual will represent USM across… more
- Imperative Care (Campbell, CA)
- …investigations on product failures. + Create, modify, and qualify test methods per FDA and regulatory requirements. + Establish and/or tune detailed requirements ... full R&D product life cycle and product design from concept to regulatory marketing approval. + MS in Engineering and experience in endovascular/neurovascular… more
- Abbott (Sylmar, CA)
- …regulatory requirements. Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating ... ability to understand and comply with applicable Food & Drug Administration ( FDA ) regulations and Company operating procedures, processes, policies and rules is… more
- Abbott (Alameda, CA)
- …assurance practices. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... team and the wider business around CAPA process, quality standards, and regulatory requirements. + Lead and/or contribute to continuous improvement initiatives and… more
- BeOne Medicines (Emeryville, CA)
- …and standards are met. Externally, the individual will interface with outside regulatory agencies and more specifically, the FDA , and business partners ... regulatory requirements + Liaises and negotiates with the FDA and Health Canada as needed for all aspects...candidates will have experience working as a lead in Regulatory Affairs with the FDA and prior… more