- 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
- Sutter Health (Castro Valley, CA)
- …Security (DHS), Drug Enforcement Administration (DEA), Food and Drug Administration ( FDA ) and United States Pharmacopeia (USP). Possess written and verbal ... communications 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
- 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
- Stryker (Irvine, CA)
- …experience is strongly preferred. + Experience in interacting with regulatory agencies ( FDA , MoH, TUV, etc.). + Understanding of US and International Medical Device ... Regulations. + Familiarity with ISO 13485, GDP, GMP. + Proven ability to represent Quality across projects, with strong communication, problem-solving, critical thinking, and cross-functional collaboration skills in a matrix environment. $100,700 - $165,100… more
- Cayuse Holdings (Oakland, CA)
- …+ 40/60hr medical training. + Experience with State Department experience/ refugees, FDA , Health & Human services, Medical, Legal, Housing Authority etc. + Must ... be able to pass a background check. May require additional background checks as required by projects and/or clients at any time during employment. + Must possess problem-solving skills. + Exceptional communication skills, both oral and written + Ability to… more
- Ascendis Pharma (Palo Alto, CA)
- …and global safety reporting regulatory requirements. + Working knowledge of FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance ... documents; working knowledge of global safety regulations. + Potentially may require travel up to 20% of the time domestically and internationally Estimated Hourly Pay: $75-90/hr DOE. Actual pay determination is dependent on a variety of factors some of which… more
- Philips (San Diego, CA)
- …right fit if:** + You have a minimum of 8+ years' experience in FDA regulated, IEC 62304 medical device software environments (SiMD/SaMD), with a focus on Software ... Design Assurance/Control, detailed knowledge of Risk Management (ISO 14971/ AAMI TIR45) and strong Understanding of all aspects of the QMS related to Design Controls. + You've acquired a minimum of 3+ years' experience in functional team leadership, including… more
- Fujifilm (Sacramento, CA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... other applicable laws, regulations, and standards. **Qualifications:** While this position is listed as a Clinical Specialist, PLEASE NOTE that candidates that do not meet the minimum qualifications for this job as listed in the job description are still… more
- Niagara Bottling LLC (Diamond Bar, CA)
- …ensure successful commissioning. + Experience working with process authorities and FDA related certification and validations + Work with appropriate cross functional ... teams to identify and implement process improvements to streamline equipment reliability. + Identify cost savings opportunities and develop business plans to realize the savings. + Travel requirement of 70%+ (domestic and international). + Please note this job… more
- Parker Hannifin Corporation (Irvine, CA)
- …to drive on-time delivery goals. + Knowledge of other government agencies (eg, FDA , EAR, ITAR, and OFAC). + Experience in Record keeping requirements, rules, and ... regulations. + Computer proficient - Microsoft Office 365 (Outlook, Work, Excel, PowerPoint). + Effective communication skills (both oral and written). + Strong interpersonal skills. + Must be eligible to obtain DoD security clearance. + Must be a US citizen… more