- 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
- 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
- Abbott (Milpitas, CA)
- …and ensures compliance with company policies and procedures (eg compliance with FDA regulations, etc.) + *Makes and executes operational decisions with a strategic ... perspective + Directs and controls the activities and budget of one or more functional areas, product groups and/or third party vendors. **QUALIFICATIONS:** + Bachelor's or MS degree in Human Factors Engineering, Biomedical Engineering, Electrical Engineering,… more
- Kelly Services (Irvine, CA)
- …writing and verball_ + _Familiarity with quality and regulatory systems including FDA 's Quality System Regulation, ISO13485_ _Applicants must be legally permitted to ... work in the United States immediately and without employer sponsorship._ As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit… more
- Stryker (Riverside, CA)
- …Must adhere rigidly to all GMP policies and procedures as stipulated by the FDA . QUALIFICATIONS: + 0-2 years in an outside sales position (medical-related fields are ... preferable). + BA or BS degree required. + Field sales training--In field training. + Successful completion of in-house product training program. + Computer training. + Medium work: Exerting up to 50 pounds of force occasionally and/or up to 20 pounds of force… more
- Gilead Sciences, Inc. (Foster City, CA)
- …knowledge of the drug development process and GVP, including global regulations ( FDA , EMA, ICH) and their application to cross-functional drug development. + ... Proficient in GxP Auditing with a successful track record of leading pharmacovigilance audits. + Thorough knowledge of standards, systems, policies, and procedures that enable QMS operations and compliance within the biopharma industry, specifically those… more
- Gilead Sciences, Inc. (Foster City, CA)
- …manufacturing sector and trends in that sector. + Familiarity with FDA and ICH guidelines relating to registration, quality, and compliance concerning ... drug substance, drug product, and devices. + Experience in managing organizational cross-functional initiatives and/or business operations programs. + Strategic thinking and ability to influence and constructively challenge the status quo. + Ability to manage… 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:** Baseline Qualifications: + Bachelor's Degree, Trade School Certification (Industry related), or Industry Experience Equivalent + One or more industry-specific certifications in relevant… more