- Terumo Neuro (Aliso Viejo, CA)
- …and to provide regular progress updates. + Support clinical science and regulatory affairs functions by utilizing medical expertise to provide input to study ... evaluation reports, clinical study reports, literature review, risk management, regulatory submissions, questions from regulatory authorities, scientific… more
- Abbott (Sylmar, CA)
- … requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... liaison to ensure designs and products are meeting customer needs and regulatory requirements. + Understands the business units products and related clinical… more
- Fujifilm (Sacramento, CA)
- …satisfaction and/or HCUS's future business activities. + Adheres to the Company's quality and regulatory compliance requirements and ensures that all job ... Provides on-going support to resolve application related and image quality concerns on both a product and system level....with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO… more
- Abbott (Alameda, CA)
- …+ Knowledge of data collection best practices for clinical trials familiarity with regulatory frameworks (eg, FDA , EMA, ICH-GCP). + Knowledge of global clinical ... to lead and manage the development, documentation, and execution of risk-based quality management process, as described in the risk assessment, data management plan,… more
- Teleflex (Pleasanton, CA)
- …* Proven communication skills with cross-functional interaction * Experience with ISO13485, MDD, FDA Quality System Regulations The pay range for this position ... driven by our purpose to improve the health and quality of people's lives. Through our vision to become...assessments, identification of CAPA's, and report generation. * Support regulatory approvals and responses to regulatory questions… more
- Abbott (Alameda, CA)
- …overall complaint handling process during audits, inspections and assessments by regulatory agencies, globally. Works closely with Commercial Teams and Commercial ... issues affecting product performance. Anticipates, recognizes, communicates and manages quality issues within the organization and works with appropriate… more
- Integra LifeSciences (Irvine, CA)
- …execution of documentation, change control, and training processes based on business, regulatory and customer requirements to ensure compliance with company and ... regulatory requirements. **DUTIES & RESPONSIBILITIES** + Initiates and executes...control and training process + Leads and participates in quality system improvement initiatives + Interface between functions /departments… more
- Abbott (Alameda, CA)
- …standards of service. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... supply chain teams including policy and procedure development, strategy formulation, regulatory compliance, quality systems and product life cycle planning.… more
- J&J Family of Companies (Santa Clara, CA)
- …products being developed. + Support company goals and objectives, policies and procedures, Quality Systems, and FDA regulations. + Other duties as assigned. ... product(s) in compliance with the company's Design Control requirements and applicable regulatory requirements. + Develop proof of concept designs and bench models… more
- University of Southern California (Los Angeles, CA)
- …to troubleshoot and resolve technical issues in a timely manner. Knowledge of regulatory requirements and guidelines (eg, FDA , EMA) related to cGMP. REQ20165292 ... preparation, cell expansion, harvesting, cryopreservation, and cell culture) and conducts quality control testing to ensure product safety, purity, and compliance,… more