- Bristol Myers Squibb (San Diego, CA)
- …Advise on global regulatory matters relevant to radiopharmaceuticals, including FDA regulations governing drug development, clinical trials, approval, labeling, ... in the biotech, pharmaceutical or life sciences industry, including significant FDA regulatory and healthcare law counseling. + Prior experience supporting oncology,… more
- Envista Holdings Corporation (Brea, CA)
- …Quality Engineer will report directly to the Quality Engineering Manager . **Job Requirements:** **ESSENTIAL DUTIES AND RESPONSIBILITIES:** + Actively participates ... and process changes. + Maintains a working knowledge of FDA GMP, ISO 13485 standards and other applicable standards....Management (VPM)). + Any duties or tasks assigned by Supervisor/ Manager . **JOB REQUIREMENTS:** + Bachelor's degree (B. S.) in… more
- Bayer (Sacramento, CA)
- …Medical Inquires in collaboration with Medical Communications; + Adherence to SOP and FDA guidance for distribution of scientific information; + Adherence to SOP and ... and collaboration with territory cross-functional stakeholders (ie Area General Manager , Area Business Unit team, Field DGOS, etc.) as...or equivalent experience is preferred; + Working knowledge of FDA , OIG requirements; + A minimum of 1 year… more
- Medtronic (Los Angeles, CA)
- …released Diabetes products. + Ensure compliance with all regulatory standards, including FDA QSR and ISO 13485. **Required Knowledge:** + Requires a Baccalaureate ... medical devices, defense, or automotive. + Familiarity with regulatory standards ( FDA QSR, ISO 13485). + Demonstrated experience generating technical documentation… more
- Danaher Corporation (Sunnyvale, CA)
- …to identify and implement improvements. This position will work with the Senior Manager Quality Systems Compliance. This position is part of the Quality department ... . + Participate in external audit management ( eg FDA , ISO, Danaher Corporate, foreign governments), in either a...and standards including compliance with Food & Drug Administration ( FDA ), ISO 13485, European Union In Vitro Diagnostic Regulation… more
- Cedars-Sinai (Beverly Hills, CA)
- …on the needs of the department. Scheduling will be determined by the hiring manager based on operational priorities. Please note that per diem team members are not ... all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board (IRB). **Primary Duties and Responsibilities** +… more
- Medtronic (Northridge, CA)
- …document design verification test protocol, plans, and reports in compliance with FDA /ISO and global regulations. + Stay current with industry standards and ... Engineering. + Familiarity with lab/testing environment. + Experience in Medical Device/ FDA Regulated Industry and compliance with IEC60601-1-2. + Familiarity with… more
- Adecco US, Inc. (Union City, CA)
- …along with other tasks as requested by the department supervisor or manager . This role requires clear knowledge of quality processes, specifically working within ... an **ISO 13485 and FDA regulated environment** . This position focuses heavily on...devices. 3. Technical experience, preferably in a **regulated environment** ( FDA , ISO 13485, etc.), that includes engineering drawings and/or… more
- Kelly Services (Petaluma, CA)
- …robust quality processes for future growth Key Responsibilities: + Assist the QA Manager in building, scaling and managing the QA team + Ensure regulatory compliance ... with GMP, FDA , ISO13485 and combination product requirements + Assist in...environment (combination product experience a plus). + Expertise in FDA regulations, ISO standards, drug/device compliance + BS/MS in… more
- Stanford University (Stanford, CA)
- …world of health care in the cancer arena. Reporting to the Clinical Research Manager , the Clinical Research Coordinator 2 will be conversant in the goals, mission ... investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed. _* -… more