- Gilead Sciences, Inc. (Foster City, CA)
- …implement integrated strategies that align with the Medical Affairs goals while ensuring compliance with ACCME, FDA , OIG, and other relevant guidelines (as well ... In this role, the Senior Director will collaborate with cross-functional teams (eg Legal, Compliance , Public Affairs, and Medical Affairs colleagues) to develop and… more
- Sharp HealthCare (San Diego, CA)
- …follow through, and prevention.Assists in maintaining CAP, JCAHO, CA state, AABB, FDA , and other accreditation and regulatory agency standards and ... and procedures to facilitate application of SHC corporate commitment to compliance guidelines.Acts as Technical Consultant regarding abnormal or unusual orders or… more
- J&J Family of Companies (Santa Clara, CA)
- …managing technology development teams + Design and develop product(s) in compliance with the company's Design Control requirements and consistent with applicable ... regulatory requirements. + Partner with the Adv. R&D and...goals and objectives, policies and procedures, Quality Systems, and FDA regulations. + Other duties as assigned. **Qualifications** +… more
- Stryker (Irvine, CA)
- …implement CAPAs for process-related issues. + Document processes, validations, and risk assessments in compliance with FDA 21 CFR Part 820, ISO 13485, and ISO ... (Minitab, JMP). + Familiarity with risk management (DFMEA, PFMEA) and regulatory expectations for Class II/III interventional devices. + Hands-on experience with… more
- Sutter Health (San Francisco, CA)
- …+ Protects patients and technicians by adhering to infection-control protocols. COMPLIANCE + Maintains strictest confidence of all patients Protected Health ... completes mandated continuing education requirements to meet facility and regulatory agencies accreditation and licensure requirements. + Develops hospital staff's… more
- Fresenius Medical Center (Apple Valley, CA)
- …Safety, DOT, and Compliance . + Remains up-to-date with all annually revised regulatory standards (OSHA, DOT, EPA, FDA , and state specific agencies). + ... Completes all necessary records and reports in a timely and accurate fashion. + Attends meetings and communicating pertinent information to assigned drivers and management. + Interacts with Operations management, Customer Service, customers, and employees +… more
- Actalent (Irvine, CA)
- …process, including the development and maintenance of risk management files, ensuring compliance with ISO 14971. + Develop and implement quality plans. + Ensure ... improvement tools, sampling plans, etc. + Provide support during regulatory audits and responses to government agency questions. Required/Preferred...of EN ISO 13485, ISO 14971, IEC 62304 and FDA QSR for Medical Devices + Ability to work… more
- Astrix Technology (Anaheim, CA)
- …year in a leadership experience. + Strong knowledge of food safety programs and regulatory standards ( FDA , USDA, AIB, HACCP, GMP, Allergen Programs). + Excellent ... and OSHA regulations at the federal, state, and local levels. + Maintain compliance with GMP, Food Safety, Food Defense, and Food Quality standards, including prompt… more
- Danaher Corporation (West Sacramento, CA)
- …budget overruns. + Utilize project management tools to track progress and ensure compliance with internal policies. The essential requirements of the job include: + ... preference for 2-5 years in program/project management. + Experience in FDA -regulated/IVDR environments strongly preferred. + PMP or equivalent certification highly… more
- Mentor Technical Group (Millbrae, CA)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With… more