- Medtronic (Northridge, CA)
- …product, regulatory, security, and device engineering teams to ensure compliance with FDA , ISO, HIPAA, GDPR, and other global standards. + Communicate effectively ... with stakeholders at all levels, ensuring transparency on priorities, risks, and progress **Minimum Requirements:** Requires a Bachelors degree and a minimum of 7 years of relevant experience with 5+ years of managerial experience, or advanced degree with a… more
- Gilead Sciences, Inc. (Foster City, CA)
- …knowledge of the drug development process and GCP, including global regulations ( FDA , EMA, ICH) and their application to cross-functional clinical development. + ... Proficient in GxP Auditing with a successful track record of leading clinical/investigator site audits. + Thorough knowledge of standards, systems, policies, and procedures that enable QMS operations and compliance within the biopharma industry, specifically… more
- Abbott (Alameda, CA)
- …such as medical devices or pharmaceutical products. + Knowledge of medical device standards including FDA QSR, ISO 13485, ISO 14971, 21 CFR Part 11 and IEC 62304. + ... Excellent oral and written communication skills. **Preferred Qualifications** + Prior design control experience preferred. + Knowledge of Jira, Confluence and/or other software development tools is a plus. + ASQ CQE or CSQE Certifications a plus. Apply Now… more
- Lactalis American Group Inc. (Tulare, CA)
- …+ Ensure compliance with all applicable regulatory and safety standards (eg, FDA , OSHA, USDA, GMP). + Develop equipment and process specifications, including ... sourcing vendors and managing installations or upgrades. + Maintain accurate documentation, including equipment manuals, drawings, SOPs, and project records. + Support plant utilities, including refrigeration, boilers, water systems, compressed air, and… more
- Pfizer (South San Francisco, CA)
- …+ Strong knowledge of clinical procedures, ICH guidelines,GCP and familiarity with FDA , EMA, and global regulations. + Strong scientific writing skills and ... communication skills (written and verbal) + Clinical document writing experience (eg, protocol, ICD, IB, IND), as well as understanding complex data analysis. + Track record of scientific productivity as evidenced by publications, posters, abstracts and/or… more
- Gilead Sciences, Inc. (Foster City, CA)
- …regulatory requirements applicable to the conduct of clinical trials and guidelines (eg, FDA , EMA, ICH) and related industry standards and trends + Through knowledge ... of the drug development process, including all key functions involved in the various stages of drug development from early research through post-marketing + Strong analytical skills to assess quality issues and lead the resolution in a collaborative manner… more
- Sutter Health (Oakland, CA)
- …Security (DHS), Drug Enforcement Administration (DEA), Food and Drug Administration ( FDA ), and United States Pharmacopeia (USP). + Possess written and verbal ... communication skills to explain sensitive information clearly and professionally to diverse audiences, including non-medical people. + Well-developed time management and organizational skills, including the ability to prioritize assignments and work within… more
- Cedars-Sinai (Los Angeles, CA)
- …all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board. **Key Responsibilities:** + Coordinates data ... for research studies. + Designs forms for data collection. + Performs clinical data collection/abstraction. + Processes clinical data using a range of computer applications and database systems to support cleaning and management of subject or patient data. +… more
- United Therapeutics (Sacramento, CA)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an… more
- ZOLL Medical Corporation (San Bernardino, CA)
- …Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to ... reduce infarct size in patients with the most severe heart attacks. Heart disease is the leading cause of death for both men and women in the US At ZOLL, your work will help to ensure cardiac patients get the life-saving therapy they need.ZOLL has been… more