- Abbott (Alameda, CA)
- …with system identification/stochastic modeling and algorithm development for sensor systems through FDA clearance or approval. **Preferred** + A master's degree or a ... glucose monitoring systems) and involvement in algorithm development support towards regulatory clearance of sensor products. + Signal processing or equivalent… more
- Oura (San Francisco, CA)
- …+ Collaborate with stakeholders in Product, Design, Science, Research, Data Science, Regulatory , Marketing and other teams across our global organization. + Mentor ... related to women's health or wellness (strongly preferred). + Experience with FDA -regulated products or other regulated health industries. + Experience with wearable… more
- BD (Becton, Dickinson and Company) (Irvine, CA)
- …complex medical device development from concept to market + Strong knowledge of regulatory requirements and quality standards in the medical device industry ( FDA ... , ISO 13485, ISO 60601) + Excellent problem-solving skills and ability to work effectively in a fast-paced, collaborative environment + Strong communication and interpersonal skills, with ability to convey technical information to non-technical stakeholders +… more
- Danaher Corporation (Brea, CA)
- …In partnership with specialist attorneys and other professionals, advise on regulatory , compliance, privacy, and litigation matters + Supervise legal professionals ... in: + Experience with healthcare regulation, including: fraud and abuse (eg, anti-kickback); FDA for medical devices; data use and privacy (eg, HIPAA, GDPR); and… more
- Cedars-Sinai (Los Angeles, CA)
- …for long term follow-up patients only. + Assists supervising staff with regulatory submissions to the Institutional Review Board (IRB) including submission of ... all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board. Maintains research practices using Good… more
- Bio-Techne (San Jose, CA)
- …customers successfully. Collaborate with cross-functional teams (development, product management, regulatory ) to ensure quality is embedded throughout the software ... environment Working knowledge of python programming language Understanding of GAMP5, FDA , and ISO regulations preferred. **Why Join Bio-Techne:** **We offer… more
- Antech Diagnostics (Fountain Valley, CA)
- …Experience in regulated industries (finance, healthcare, manufacturing, etc.) applying regulatory regulations and/or security frameworks under a quality management ... AZ-505, AZ-400, SC-900 are a plus. + Experience working in a regulated ( FDA , MDR) environment with medical instrumentation is a plus. **Physical Demands:** +… more
- Sutter Health (Mountain View, CA)
- …adequate stock levels, checking accuracy of pricing, and completing required regulatory documentation. Adheres to all standards, procedures, cleaning protocols, and ... Homeland Security (DHS), Drug Enforcement Administration (DEA), Food and Drug Administration ( FDA ) and United States Pharmacopeia (USP). + Possess written and verbal… more
- VTI Life Sciences (Los Angeles, CA)
- …(Mechanical Eng., Chemical Eng., Chemistry, Biology, etc.). + 5+ years of relevant FDA -regulated industry experience. + Candidates must be local to the LA area as ... travel expenses are not allowed. + Knowledge of cGMP and other regulatory standards. + Proficiency in Project Engineering and construction-related activities +… more
- AbbVie (Irvine, CA)
- …Requirements: * Responsible for performing all duties in compliance with FDA 's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, ... and all other international regulatory requirements with which ZELTIQ complies. Additional Information All your information will be kept confidential according to… more