- Genentech (South San Francisco, CA)
- …deliver high quality bioanalytical methods and data in compliance with global regulatory and industry standards with a lean organizational footprint and efficient ... and clinical studies through global CROs in compliance with international regulatory standards. The leader oversees and manages gRED's global bioanalytical CRO… more
- Roche (Carlsbad, CA)
- …Lead for Companion Diagnostics, you will be a member of the companion diagnostics Regulatory Affairs Leadership team. In this position, you will be a leading figure ... and key point of contact for Roche Diagnostics' regulatory capabilities in CDx. You will improve the Subchapter's overarching expertise based on current and upcoming… more
- Gilead Sciences, Inc. (Oceanside, CA)
- …long-term career development. The Director ensures compliance with global regulatory requirements, marketing authorization holder expectations, and internal quality ... + Performs a wide variety of activities to ensure compliance applicable regulatory requirements, to facilitate compliance with regulatory agencies, customer and… more
- Genentech (South San Francisco, CA)
- …have strong collaboration with cross-functional teams, including clinical research, regulatory affairs, and product development, to ensure the successful progression ... require a strong understanding of cardiovascular diseases, clinical trial protocols, regulatory requirements, and possibly interactions with regulatory agencies… more
- Bristol Myers Squibb (Brisbane, CA)
- …lives. Read more: careers.bms.com/working-with-us . **Associate Director, Global Regulatory Strategy, Neuroscience** **Position Summary:** The selected candidate ... will have leadership responsibility for global regulatory strategy within a development team (DT). Serve as team lead or co-lead of marketing application submission… more
- Medtronic (Irvine, CA)
- …**Collaboration:** Provide specifications and directions to clinicians/statistical programmers. + ** Regulatory Support:** Support the regulatory review and ... statistical analysis plan for the study, if required. + ** Regulatory Agency Interaction:** Take a leadership role in responding...for paid sick time, as required under applicable state law , and the Employee Stock Purchase Plan. Please note… more
- J&J Family of Companies (Irvine, CA)
- …medical direction of our structural heart business, ensuring compliance with regulatory standards and driving innovation in medical technology development. This role ... key customers and stakeholders (Key Opinion Leaders, Interventional Cardiologists, Regulatory Agencies, Professional Societies, etc.) to anticipate industry trends,… more
- Medtronic (Santa Clara, CA)
- …quality programs for medical devices. The role ensures compliance with regulatory standards and supports quality improvement initiatives. This hybrid position is ... ensuring full compliance with FDA, ISO 13485, and other regulatory requirements + Lead audit and inspection preparation activities,...for paid sick time, as required under applicable state law , and the Employee Stock Purchase Plan. Please note… more
- Stanford University (Stanford, CA)
- …the School of Medicine (SoM). The ABSO will provide technical, regulatory , and administrative support to Stanford's Institutional Biosafety Committee (IBC), which ... with rDNA and infectious agents, while ensuring compliance with regulatory requirements and nurturing productive relationships with principal investigators (PIs)… more
- Medtronic (Los Angeles, CA)
- …Medtronic Diabetes products. This role ensures compliance with global regulatory requirements, drives cross-functional collaboration, and oversees the timely ... of field actions to protect patient safety and maintain regulatory compliance. This position is an exciting opportunity to...for paid sick time, as required under applicable state law , and the Employee Stock Purchase Plan. Please note… more