- AbbVie (South San Francisco, CA)
- …+ Pharmaceutical experience with clinical trials, including familiarity with expectations of regulatory agencies, especially FDA and EMEA. NDA/BLA or other ... related to output design and programming conventions. Responsible for monitoring regulatory guidance and industry best practices. *Case report forms and database… more
- Medtronic (Northridge, CA)
- …concise, and well-structured biocompatibility evaluation plans and reports to support regulatory submissions. The Senior Product Engineer applies scientific rigor in ... including the preparation of technical protocols and reports, as well as drug compatibility studies related to biocompatibility evaluations. The role also supports… more
- Cardinal Health (Sacramento, CA)
- …with investigators participating in ongoing studies + Maintain current knowledge of FDA regulations and internal policies regarding Medical Drug Information, ... hours. We also provide customers the support they need in regulatory compliance, reimbursement, continuing education, information management and other crucial areas,… more
- Sutter Health (Sunnyvale, CA)
- …of Human Services (DHS), Drug Enforcement Administration (DEA), Food and Drug Administration ( FDA ) and the United States Pharmacopeia (USP) organization. ... adequate stock levels, checking accuracy of pricing, and completing required regulatory documentation. Adheres to all standards, procedures, cleaning protocols, and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …be responsible for leading the development and commercialization of small molecule drug product including proteins/peptides from drug discovery to product ... activities across all development stages (lead optimization of pre-clinical drug candidates, preformulation, formulation development, process scale-up, technology transfer,… more
- Stryker (San Jose, CA)
- …this role, you will collaborate closely with cross-functional teams, including Regulatory , Clinical, Quality, and Marketing to ensure the successful preparation of ... sub-groups. Interprets literature information and synthesizes the information in clinical regulatory documents. + Addresses notified body feedback on EU clinical… more
- Children's Hospital Los Angeles (Los Angeles, CA)
- …and/or regulatory research Preferred: * Knowledge of Food and Drug Administration ( FDA ) regulations and International Conference on Harmonization (ICH) ... monitoring initiatives, evaluating research integrity, and ensuring adherence to institutional, regulatory , and ethical standards. The position serves as a mentor… more
- Abbott (Sylmar, CA)
- …and other regulatory requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, ... method validation activities. + Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps. +… more
- Stryker (San Jose, CA)
- …improvement projects while applying software industry practices, compliance standards and guidance ( FDA /HHS). + Act as a subject matter expert on all related ... Research & Development (R&D), Quality (QA/QC), Information Technology, Healthcare IT, Regulatory Affairs (RA) or Technology industry. + Previous employment at… more
- Cordis (Irvine, CA)
- …in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral ... for risk mitigation to ensure the safety and efficacy of medical devices. + Regulatory Compliance: Stay up to date with regulatory requirements, standards, and… more