- Edwards Lifesciences (Irvine, CA)
- …and commercialization in collaboration with cross-functional teams (eg, Marketing, Clinical Affairs , Regulatory Affairs , Legal) + Establish relationships ... at the heart of everything we do. As part of our Medical Affairs team, you'll foster internal and external collaboration to generate and disseminate evidence-based… more
- Unilever (El Segundo, CA)
- …cross functional collaboration within all levels of the business but in particular with Regulatory Affairs , Brand Marketing and Sales. The ideal candidate has a ... topics to ensure up to date substantiation. + Work closely with Regulatory Affairs to develop effective cross functional processes for claims substantiation. +… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …decision, as applicable. + Collaborates with leadership in Business Unit Quality, Regulatory Affairs , R&D, Operations, Service, Medical Affairs , Legal, ... creation and management of communications with FDA and other regulatory agencies, 2) ensuring that commitments made to the...ensuring that commitments made to the FDA and other regulatory agencies (eg, recall letters) are implemented at the… more
- Envista Holdings Corporation (Brea, CA)
- …Manage the submission process for marketing materials requiring review and approval from Regulatory Affairs and Legal Affairs , ensuring all assets comply ... and regional marketing teams, creative agencies, and internal departments (including Regulatory and Legal) to ensure seamless communication and efficient project… more
- Actalent (Irvine, CA)
- …teams to align SOPs with business and compliance needs. + Partner with Regulatory Affairs to ensure claims meet global regulatory requirements. ... (Master's preferred). + 8-10 years of experience in Quality Systems or Regulatory Affairs within the medical device industry. + Strong understanding of FDA… more
- UCLA Fielding School of Public Health (Los Angeles, CA)
- …and knowledge of FDA regulatory pathways. * ACRP certification, expertise in regulatory affairs and regulatory submissions, IND filings, engagement with ... of FDA regulatory pathways. * ACRP certification, expertise in regulatory affairs and regulatory submissions, IND filings, engagement with the FDA,… more
- BeOne Medicines (San Mateo, CA)
- …The ideal candidate will have a strong background in research, clinical development, regulatory affairs , and safety, with a particular focus on process ... focus on R&D. + Proven expertise and understanding of research, clinical development, regulatory affairs , and safety processes, workflows and analytics. + Strong… more
- Pfizer (South San Francisco, CA)
- …and analysis. The medical director works closely with other functions such as regulatory affairs , pharmacovigilance, biostatistics, and medical affairs to ... that the clinical development program meets the scientific, ethical, and regulatory standards. The medical director also provides medical expertise and guidance… more
- Actalent (Irvine, CA)
- …meet business needs. + Work cross-functionally with departments such as R&D, Regulatory Affairs , Regulatory Compliance, Source Quality, Lifecycle Management, ... ETQ is a must. + Strong skills in Compliance, Quality Assurance, and Regulatory Affairs . + Knowledge of working with and executing a quality plan and updating… more
- Pfizer (South San Francisco, CA)
- …design, conduct, and analysis. They work closely with other functions such as regulatory affairs , pharmacovigilance, biostatistics, and medical affairs to ... ensure that the clinical development program meets the scientific, ethical, and regulatory standards. They also provides medical expertise and guidance to the… more