- Stanford University (Stanford, CA)
- …and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. + Proven ... + Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close-out. + Determine eligibility… more
- J&J Family of Companies (Santa Clara, CA)
- …are designed and developed in accordance with customer, corporate, and regulatory guidelines as well as working closely with Design, Manufacturing Engineering ... with a focus on process improvements and design control compliance in accordance with ISO 13485, ISO 14971, 21...sufficient clarity, detail and correctness to be submitted for regulatory review with confidence. Must be able to review… more
- Sutter Health (Berkeley, CA)
- …billing, pricing, record keeping and provision of services required to meet regulatory requirements. *Maintains records of drug distribution, works with vendors to ... liaise with pharmaceutical manufacturers and assistance programs. + **Accreditation & Compliance ** : Ensure compliance with accreditation standards (eg, URAC,… more
- J&J Family of Companies (Irvine, CA)
- …independently; creating reports intended for internal distribution and for regulatory submission; creating internal presentations and white papers; and interfacing ... 1 and 2 job descriptions. + Interact with Biostatistics, Data Management, Regulatory , and Clinical staff to define and clarify project requirements. + Design… more
- Abbott (Pleasanton, CA)
- …qualifications. You will manage project timelines, budgets, and deliverables, ensuring compliance with regulatory requirements. **What You'll Work On** + ... project teams** to drive supplier quality initiatives, ensuring alignment with medical device regulatory standards (eg, FDA , ISO 13485). + **Develop and manage… more
- Philips (San Diego, CA)
- …tools, and innovative methodologies to continuously enhance software quality and regulatory compliance . + Will oversee the development, maintenance, and ... of software designs/inputs, overseeing the review of test/performance data to ensure compliance with quality, safety, and regulatory standards, while identifying… more
- Stanford University (Stanford, CA)
- …to precision medicine in mental health and neuroimaging trials + Experience with FDA regulatory procedures and reporting + Demonstrated capacity to solve ... activities through RedCap and completing study documents and forms. + Ensure compliance with research protocols, review and audit study forms for completion and… more
- Children's Hospital Los Angeles (Los Angeles, CA)
- …* 5 years' clinical research experience. * 1 years' experience in clinical research compliance and/or regulatory research Preferred: * Knowledge of Food and Drug ... Office (CRO), providing expert oversight and strategic insight into the quality and compliance of clinical research activities at CHLA. This role is responsible for… more
- Cordis (Irvine, CA)
- …for risk mitigation to ensure the safety and efficacy of medical devices. + Regulatory Compliance : Stay up to date with regulatory requirements, standards, ... developing, implementing, and continuously improving quality management systems, ensuring compliance with regulations, standards, and customer requirements. The position… more
- Medtronic (Northridge, CA)
- …for leading biological evaluations within a risk management framework, ensuring compliance with ISO 10993 standards and global medical device regulations. This ... concise, and well-structured biocompatibility evaluation plans and reports to support regulatory submissions. The Senior Product Engineer applies scientific rigor in… more