- Amgen (Thousand Oaks, CA)
- …technical assessments with service providers on reusable shipping solutions, ensuring compliance and alignment with corporate sustainability goals + Ability to ... priorities in a very dynamic environment + Experience in project management and FDA type Quality Management Systems + Ability to lead projects independently and take… more
- Cordis (Irvine, CA)
- …(Coronary)** role is a key position within the coronary program to help ensure FDA clearance through a PMA approval of this innovative device is granted and patients ... sites and activities to ensure adherence to appropriate US and OUS regulations, compliance with the study Protocol(s), and applicable local regulations + Manage and… more
- Danaher Corporation (Brea, CA)
- …partnership with specialist attorneys and other professionals, advise on regulatory, compliance , privacy, and litigation matters + Supervise legal professionals and ... 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
- Terumo Medical Corporation (San Francisco, CA)
- …use. Demonstrate a commitment to patient safety and product quality by maintaining compliance with all TMC Quality Systems requirements. This includes but is not ... new product development and clinical activities. Fully adhere to all applicable FDA regulations, international guidelines and Terumos policies at all times. Perform… more
- Abbott (San Diego, CA)
- …build productive internal/external working relationships + Carries out duties in compliance with established business policies + Other duties as assigned, according ... regulations (ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls, FDA SW Guidelines ). + Experience in delivering products for the Medical Device… more
- Abbott (Temecula, CA)
- …to all sites and customers. Must ensure that all molds are run in compliance with all quality standards and procedures. **EDUCATION AND EXPERIENCE YOU'LL BRING:** + ... device industry. + Knowledge of plastics processes, resins, tooling required. Knowledge of FDA QSR's and ISO requirements preferred. **WHAT WE OFFER :** At Abbott,… more
- Antech Diagnostics (Fountain Valley, CA)
- …+ Integrate security principles into the Software Development Lifecycle, ensuring compliance with security and privacy policies, standards and guidelines. + Conduct ... 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
- Gilead Sciences, Inc. (Foster City, CA)
- …**Preferred Qualifications:** + Background in AI governance, risk management or compliance within pharma or similar regulated industries. + Familiarity with ... (eg, Docker, Kubernetes). + Knowledge of AI-related regulatory frameworks (eg, HIPAA, GDPR, FDA , EU AI Act). + Strong grasp of ML algorithms and tuning techniques.… more
- Gilead Sciences, Inc. (Foster City, CA)
- …SOPs, Work Instructions, business policies and procedures to ensure GxP compliance . Influence cross-functional SOP content and review/approve as required. + Oversees ... for clinical studies, and, in comparator sourcing strategy. + Expert knowledge of the FDA GxP standards and regulatory guidance documents such as CFR, Annex 13, EU… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and transfer activities. * Contribute to quality improvement initiatives and ensure compliance with relevant regulations and standards, including FDA 21 CFR ... Your Rights' (https://www.eeoc.gov/employers/eeo-law-poster) poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/ compliance /posters/eppac.pdf) YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE… more