- Cardinal Health (Sacramento, CA)
- …False Claims Act, Civil Monetary Penalties Law, Stark, Beneficiary Inducement Statutes), FDA regulation (Food, Drug & Cosmetic Act), and privacy (HIPAA). ... to commercial, corporate securities, intellectual property, labor and employment, and regulatory law, among other areas. This function also litigates all company… more
- Gilead Sciences, Inc. (Foster City, CA)
- …input into clinical development documentation, scientific publications and presentations, and regulatory filings. Dependent upon the area of assignment, you may lead ... input into clinical development documentation, scientific publications and presentations and regulatory documentation. + May participate in or lead special projects… more
- Cytel (Sacramento, CA)
- …motivate a strong team of consultants and analysts. + Experience interacting with regulatory agencies ( FDA /EMA) and key opinion leaders to enhance development ... in related areas (adaptive designs, clinical development, data science, model-informed drug development), to provide strategic advice to define optimal regulatory… more
- Stryker (Irvine, CA)
- …+ Medical device industry experience is strongly preferred. + Experience in interacting with regulatory agencies ( FDA , MoH, TUV, etc.). + Understanding of US and ... to enhance quality performance across the business and for customers while ensuring regulatory standards and compliance. **What You Will Do:** + Work closely with… more
- Abbott (Sylmar, CA)
- …and other regulatory requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, ... + Remains current on developments in field(s) of expertise, applicable regulatory requirements, and a general knowledge of the company's products, markets,… more
- Abbott (Pleasanton, CA)
- …finance management and/or the groups supported. + Comply with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company ... focus on Finance tasks supporting Heart Failure Medical Affairs and Clinical/ Regulatory Functions. This includes preparing financial budgets, workforce planning &… more
- Abbott (Sylmar, CA)
- …and other regulatory requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, ... liaison to ensure designs and products are meeting customer needs and regulatory requirements. + Understands the business units products and related clinical… more
- University of Southern California (San Diego, CA)
- …Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s). Duties will include but are not limited to: + ... and other monitoring visit activities. + Confirm sites are following GCP, regulatory requirements, study protocol, and ATRI policies. Work with sites to document… more
- Abbott (Sylmar, CA)
- …and other regulatory requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, ... + Collaborating with other organizations within the company as needed: engineering, regulatory , human factors, quality, marketing, etc + Provides input to the risk… more
- Abbott (Temecula, CA)
- …and other regulatory requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, ... products for treatment of vascular disease. Our extensive portfolio includes drug -eluting stents, bare metal stents, guide wires, balloon dilatation catheters,… more