- Fujifilm (Sacramento, CA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... consistently high level of customer satisfaction. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that… more
- Abbott (Alameda, CA)
- …spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues ... where you can grow the career you dream of. + Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …and regulatory environment. + Project management experience for complex medical device systems. PMP certification or equivalent project management ... of possible** BD is one of the largest global medical technology companies in the world. Advancing the world...and effectiveness in R&D project management. + Compliance and Quality : Ensure all R&D programs comply with regulatory… more
- J&J Family of Companies (Irvine, CA)
- …study team; + Cooperates with cross-functional teams (Research & Development, Complaint Handling, Quality / Regulatory , Medical Affairs, Medical Safety) to ... + Cooperation with the necessary stakeholders (clinical study team, medical , clinical sites, regulatory , data management) on...+ Clinical/ medical background is a plus. + Medical device experience is highly preferred. +… more
- Amgen (Thousand Oaks, CA)
- …+ Collaborating extensively with internal and external stakeholders including manufacturing, quality , regulatory , suppliers, and senior leadership. **What we ... by senior leadership. + Lead/support the authorship and management of regulatory filings, address agency questions, and represent PCE during audits. +… more
- ABM Industries (Carlsbad, CA)
- …and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies. + Understands and is aware of the quality consequences which ... improper performance of their specific job. Has awareness of device defects that may occur in their area of...Quality system requirements, as well as internal and regulatory audits. + Ensure compliance with all Facilities and… more
- Stryker (Mountain View, CA)
- …2 years related technical experience (telecom, video/audio system installation, electrical/construction, medical device , hospital biomed) + High School Diploma ... accurate manner. Provides project updates to relevant stakeholders. Coordinates with Quality to ensure compliance with regulatory and operational requirements.… more
- Abbott (Temecula, CA)
- …communicate to all levels of the organization **Preferred Experience** + Medical Device Experience Highly Preferred. Apply Now (https://www.jobs.abbott/us/en) ... ideas. ORGANIZATIONAL INTERFACE * Interfaces primarily with internal company contacts ( Quality , Supply Chain, Regulatory , R&D). Communicates very frequently with… more
- J&J Family of Companies (Santa Clara, CA)
- …for evaluations. + Collaborate with R&D, Marketing, Medical Safety, Regulatory Affairs, Clinical Engineering, and Quality Engineering to design, evaluate, ... human factors engineering. + Solid understanding of ISO 14971 and IEC 62304. + Medical Device product development or experience working in a highly regulated… more
- Cedars-Sinai (Los Angeles, CA)
- …completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB. Provides limited patient contact with research ... or contact for long term follow-up research participants only. *Assists with regulatory submissions to the Institutional Review Board (IRB) and works closely with… more